Adoport 5 mg Uses

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What is Adoport 5 mg?

Adoport 5 mg lowers your body's immune system. The immune system helps your body fight infections. The immune system can also fight or "reject" a transplanted organ such as a liver or kidney. This is because the immune system treats the new organ as an invader.

Adoport 5 mg is used together with other medicines to prevent your body from rejecting a heart, liver, or kidney transplant.

The Astragraf XL and Adoport 5 mg brands of Adoport 5 mg is generally not used for liver transplants.

Adoport 5 mg may also be used for purposes not listed in this medication guide.

Adoport 5 mg indications

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Prophylaxis of Organ Rejection in Kidney Transplant

Adoport 5 mg (Adoport 5 mg capsules, USP) is indicated for the prophylaxis of organ rejection in patients receiving allogeneic kidney transplants. It is recommended that Adoport 5 mg be used concomitantly with azathioprine or mycophenolate mofetil (MMF) and adrenal corticosteroids. Therapeutic drug monitoring is recommended for all patients receiving Adoport 5 mg.

Prophylaxis of Organ Rejection in Liver Transplant

Adoport 5 mg (Adoport 5 mg capsules, USP) is indicated for the prophylaxis of organ rejection in patients receiving allogeneic liver transplants. It is recommended that Adoport 5 mg be used concomitantly with adrenal corticosteroids. Therapeutic drug monitoring is recommended for all patients receiving Adoport 5 mg.

Prophylaxis of Organ Rejection in Heart Transplant

Adoport 5 mg (Adoport 5 mg capsules, USP) is indicated for the prophylaxis of organ rejection in patients receiving allogeneic heart transplants. It is recommended that Adoport 5 mg be used concomitantly with azathioprine or mycophenolate mofetil (MMF) and adrenal corticosteroids. Therapeutic drug monitoring is recommended for all patients receiving Adoport 5 mg.

Limitations of Use

Adoport 5 mg (Adoport 5 mg capsules, USP) should not be used simultaneously with cyclosporine.

Adoport 5 mg injection should be reserved for patients unable to take Adoport 5 mg capsules orally.

Use with sirolimus is not recommended in liver and heart transplant. The safety and efficacy of Adoport 5 mg with sirolimus has not been established in kidney transplant.

How should I use Adoport 5 mg?

Use Adoport 5 mg ointment as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Adoport 5 mg ointment.

Uses of Adoport 5 mg in details

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Adoport 5 mg is used with other medications to prevent rejection of a kidney, heart, or liver transplant. The injection form of the medication is used when you cannot take the medication by mouth. As soon possible, your doctor will switch you to the form of this medication that is taken by mouth. This medication belongs to a class of drugs known as immunosuppressants. It works by weakening your body's defense system (immune system) to help your body accept the new organ as if it were your own.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used to treat a certain type of bowel condition (severe fulminant Crohn's disease) in patients who have not been successfully treated by the usual treatment. This medication may also be used to prevent rejection of other types of transplant (such as lung).

How to use Adoport 5 mg intravenous

This medication is given by injection into a vein by a health care professional.

Dosage is based on your weight, medical condition, blood test results (e.g., Adoport 5 mg trough levels), and response to treatment.

Tell your doctor if your condition worsens.

Adoport 5 mg description

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Adoport 5 mg capsules are available for oral administration containing the equivalent of anhydrous Adoport 5 mg 0.5 mg, 1 mg or 5 mg. Adoport 5 mg Sandoz also contains the following inactive ingredients: Capsule Contents: Croscarmellose sodium, hypromellose, lactose monohydrate and magnesium stearate. Capsule Shell: Gelatin, titanium dioxide, yellow iron oxide (0.5- and 1-mg cap); red iron oxide (1- and 5-mg cap); black iron oxide (1-mg cap only). Printing Ink: Ammonia, black iron oxide, butyl alcohol, potassium hydroxide, propylene glycol and shellac.

Adoport 5 mg is designated as [3S-[3R*[E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]]- 5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate.

Adoport 5 mg has a molecular formula of C44H69NO12·H2O and a formula weight of 822.03. Adoport 5 mg appears as white crystals or crystalline powder. It is practically insoluble in water, freely soluble in ethanol and very soluble in methanol and chloroform.

Adoport 5 mg dosage

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Adult Adoport 5 mg Ointment 0.03% and 0.1%

Apply a thin layer of Adoport 5 mg Ointment to the affected skin twice daily. The minimum amount should be rubbed in gently and completely to control signs and symptoms of atopic dermatitis. Stop using when signs and symptoms of atopic dermatitis resolve.
If signs and symptoms (e.g. itch, rash, and redness) do not improve within 6 weeks, patients should be re-examined by their healthcare provider to confirm the diagnosis of atopic dermatitis.
Continuous long-term use of topical calcineurin inhibitors, including Adoport 5 mg Ointment should be avoided, and application should be limited to areas of involvement with atopic dermatitis.

The safety of Adoport 5 mg Ointment under occlusion, which may promote systemic exposure, has not been evaluated. Adoport 5 mg Ointment should not be used with occlusive dressings.

PEDIATRIC – FOR CHILDREN 2-15 YEARS

Adoport 5 mg Ointment 0.03%

Apply a thin layer of Adoport 5 mg Ointment, 0.03% to the affected skin twice daily. The minimum amount should be rubbed in gently and completely to control signs and symptoms of atopic dermatitis. Stop using when signs and symptoms of atopic dermatitis resolve.
If signs and symptoms (e.g. itch, rash, and redness) do not improve within 6 weeks, patients should be re-examined by their healthcare provider to confirm the diagnosis of atopic dermatitis.
Continuous long-term use of topical calcineurin inhibitors, including Adoport 5 mg Ointment should be avoided, and application should be limited to areas of involvement with atopic dermatitis.

The safety of Adoport 5 mg Ointment under occlusion, which may promote systemic exposure, has not been evaluated. Adoport 5 mg Ointment should not be used with occlusive dressings.

Adoport 5 mg interactions

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What other drugs will affect Adoport 5 mg?

Systemically available Adoport 5 mg is metabolised by hepatic CYP3A4. There is also evidence of gastrointestinal metabolism by CYP3A4 in the intestinal wall. Concomitant use of substances known to inhibit or induce CYP3A4 may affect the metabolism of Adoport 5 mg and thereby increase or decrease Adoport 5 mg blood levels.

It is recommended to monitor Adoport 5 mg blood levels whenever substances which have the potential to alter CYP3A metabolism or otherwise influence Adoport 5 mg blood levels are used concomitantly, and to adjust the Adoport 5 mg dose as appropriate in order to maintain similar Adoport 5 mg exposure.

CYP3A4 Inhibitors Potentially Leading to Increased Adoport 5 mg Blood Levels: Clinically, the following substances have been shown to increase Adoport 5 mg blood levels: Strong interactions have been observed with antifungal agents eg, ketoconazole, fluconazole, itraconazole and voriconazole, macrolide antibiotic erythromycin or HIV protease inhibitors (eg, ritonavir). Concomitant use of these substances may require decreased Adoport 5 mg doses in nearly all patients. Pharmacokinetics studies have indicated that the increase in blood levels is mainly a result of increase in oral bioavailability of Adoport 5 mg owing to the inhibition of gastrointestinal metabolism. Effect on hepatic clearance is less pronounced.

Weaker interactions have been observed with clotrimazole, clarithromycin, josamycin, nifedipine, nicardipine, diltiazem, verapamil, danazol, ethinylestradiol, omeprazole and nefazodone.

In vitro: The following substances have been shown to be potential inhibitors of Adoport 5 mg metabolism: Bromocriptine, cortisone, dapsone, ergotamine, gestodene, lidocaine, mephenytoin, miconazole, midazolam, nilvadipine, norethindrone, quinidine, tamoxifen, (triacetyl) oleandomycin.

Grapefruit juice has been reported to increase the blood level of Adoport 5 mg and should therefore be avoided.

Lansoprazol and ciclosporin may potentially inhibit CYP3A4-mediated metabolism of Adoport 5 mg and thereby, increase Adoport 5 mg whole blood concentrations.

Other Interactions Potentially Leading to Increased Adoport 5 mg Blood Levels: Adoport 5 mg is extensively bound to plasma proteins. Possible interactions with other active substances known to have high affinity for plasma proteins should be considered (eg, NSAIDs, oral anticoagulants or oral antidiabetics).

Other potential interactions that may increase systemic exposure of Adoport 5 mg include prokinetic agents (eg, metoclopramide and cisapride), cimetidine and magnesium-aluminium-hydroxide.

CYP3A4 Inducers Potentially Leading to Decreased Adoport 5 mg Blood Levels: Clinically, the following substances have been shown to decrease Adoport 5 mg blood levels: Strong interactions have been observed with rifampicin, phenytoin, St. John’s wort (Hypericum perforatum) which may require increased Adoport 5 mg doses in almost all patients. Clinically significant interactions have also been observed with phenobarbital. Maintenance doses of corticosteroids have been shown to reduce Adoport 5 mg blood levels.

High dose prednisolone or methylprednisolone administered for the treatment of acute rejection have the potential to increase or decrease Adoport 5 mg blood levels.

Carbamazepine, metamizole and isoniazid have the potential to decrease Adoport 5 mg concentrations.

Effect of Adoport 5 mg on the Metabolism of Other Drugs: Adoport 5 mg is a known CYP3A4 inhibitor; thus, concomitant use of Adoport 5 mg with drugs known to be metabolised by CYP3A4 may affect the metabolism of such medicinal products.

The t½ of ciclosporin is prolonged when Adoport 5 mg is given concomitantly. In addition, synergistic/additive nephrotoxic effects can occur. For these reasons, the combined administration of ciclosporin and Adoport 5 mg is not recommended and care should be taken when administering Adoport 5 mg to patients who have previously received ciclosporin.

Adoport 5 mg has been shown to increase the blood level of phenytoin.

As Adoport 5 mg may reduce the clearance of steroid-based contraceptives leading to increased hormone exposure, particular care should be exercised when deciding upon contraceptive measures.

Limited knowledge of interactions between Adoport 5 mg and statins is available. Clinical data suggest that the pharmacokinetics of statins are largely unaltered by the co-administration of Adoport 5 mg.

Animal data have shown that Adoport 5 mg could potentially decrease the clearance and increase the half-life of pentobarbital and antipyrine.

Other Interactions Leading to Clinically Detrimental Effects: Concurrent use of Adoport 5 mg with medicinal products known to have nephrotoxic or neurotoxic effects may increase these effects (eg, aminoglycosides, gyrase inhibitors, vancomycin, cotrimoxazole, NSAIDs, ganciclovir or aciclovir).

Enhanced nephrotoxicity has been observed following the administration of amphotericin B and ibuprofen in conjunction with Adoport 5 mg.

As Adoport 5 mg treatment may be associated with hyperkalaemia, or may increase preexisting hyperkalaemia, high potassium intake, or potassium-sparing diuretics (eg, amiloride, triamterene or spironolactone) should be avoided.

Immunosuppressants may affect the response to vaccination and vaccination during treatment with Adoport 5 mg may be less effective. The use of live attenuated vaccines should be avoided.

Incompatibilities: Adoport 5 mg is not compatible with polyvinylchloride (PVC). Tubing, syringes and other equipment used to prepare a suspension of Adoport 5 mg capsule contents must not contain PVC.

Adoport 5 mg side effects

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What are the possible side effects of Adoport 5 mg?

Kidney Transplantation: The most common adverse reactions reported were infection, tremor, hypertension, decreased renal function, constipation, diarrhea, headache, abdominal pain and insomnia. Many of these adverse reactions were mild and responded to a reduction in dosage. Insulin-dependent post transplant diabetes mellitus (PTDM) was related to increased whole blood trough concentrations of Adoport 5 mg and higher doses of corticosteroids. The median time to onset of PTDM was 68 days.

Liver Transplantation: The principal adverse reactions of Adoport 5 mg are tremor, headache, diarrhea, hypertension, nausea and abnormal renal function. These occur with oral and IV administration of Adoport 5 mg and may respond to a reduction in dosing. Diarrhea was sometimes associated with other gastrointestinal complaints eg, nausea and vomiting.

Hyperkalemia and hypomagnesemia have occurred in patients receiving Adoport 5 mg therapy. Hyperglycemia has been noted in many patients; some may require insulin therapy.

Heart Transplantation: The more common adverse reactions in Adoport 5 mg-treated heart transplant recipients were abnormal kidney fuction, hypertension, diabetes mellitus, CMV infection, tremor, hyperglycemia, leukopenia, infection and hyperlipemia.

Rheumatoid Arthritis: The adverse events associated with Adoport 5 mg treatment in rheumatoid arthritis patients, occurred at a lower rate of incidence than seen in transplant patients receiving Adoport 5 mg. The majority of adverse events were mild or moderate in intensity, of limited duration and did not result in discontinuation of the study drug.

Clinical Trial Adverse Drug Reactions: Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates.

Kidney Transplantation: The incidence of adverse events was determined in 2 randomized Phase III comparative kidney transplant studies involving 508 patients receiving Adoport 5 mg and 352 patients receiving cyclosporine. Adverse events that occurred in ≥15% of Adoport 5 mg-treated patients (combined study results) are presented for the 2 controlled trials in kidney transplantation:

Adoport 5 mg has been studied in combination with azathioprine and steroids (triple therapy) in recipients of kidney transplants. In a Phase II European trial, Adoport 5 mg triple therapy was administered to 31 adults receiving deceased donor kidney transplants. Within 6 weeks posttransplant there were no deaths or graft losses. 6 patients (19.4%) experienced acute rejection, with 1 patient experiencing corticosteroid-resistant rejection. 3 patients (9.7%) developed transient hyperglycemia, but no patient required long-term therapy for diabetes. Other adverse events reported frequently included infections (51.6%), minor neurological disorders (54.8%), and hypertension (48.8%) (Transpl Int 1995;8:86-90.). The University of Pittsburgh has studied double therapy (Adoport 5 mg and steroids) compared to triple therapy in 204 adult recipients of kidney transplants between August 1991 and October 1992. (Clin Transplantation 1994;8:508- 515). The 1 year actuarial patient and graft survival of double therapy were 95% and 90% versus 91% and 82% for triple therapy (p=NS). The incidence of rejection was significantly lower with triple therapy in deceased donor recipients (39% versus 58%) but not significantly different in recipients from living-related donors. New onset diabetes was seen in 20.2% of double therapy patients versus 7.7% of triple therapy patients. A U.S. Phase II trial studied 92 adult recipients of deceased donor kidney transplants randomized to 3 target whole blood concentration ranges of Adoport 5 mg. All patients received antilymphoblast globulin induction with azathioprine and steroids followed by Adoport 5 mg triple therapy initiated within 2 weeks posttransplant. With follow-up to 6 weeks posttransplant there were no patient deaths, and 1 graft loss. The incidence of rejection was 14% combining all Adoport 5 mg treatment groups. Adverse events requiring dose reduction were significantly associated with target Adoport 5 mg blood concentrations (36-62%).

Data on the safety and efficacy of Adoport 5 mg in combination with immunosuppressants other than steroids in liver transplant patients is more limited. In the European multicentre liver transplant study, many patients received azathioprine or ATG/ALG when Adoport 5 mg therapy was withheld. Seven patients received azathioprine in combination with Adoport 5 mg and steroids. Of these 7 patients, 1 died and 1 lost their graft in the 1st year posttransplant.

Liver Transplantation: The incidence of adverse events was determined in 2 randomized comparative liver transplant trials among 514 patients receiving Adoport 5 mg and steroids and 515 patients receiving a CBIR. The proportion of patients reporting >1 adverse event was 99.8% in the Adoport 5 mg group and 99.6% in the CBIR group. Precautions must be taken when comparing the incidence of adverse events in the US study to that in the European study. The 12-month posttransplant information from the US study and from the European study is presented. The 2 studies also included different patient populations and patients were treated with immunosuppressive regimens of differing intensities. Adverse events reported in ≥15% in Adoport 5 mg patients (combined study results) are presented in table 13 for the 2 controlled trials in liver transplantation.

Heart Transplantation:The more common adverse reactions in Adoport 5 mg-treated heart transplant recipients were kidney function abnormal, hypertension, diabetes mellitus, CMV infection, tremor, hyperglycemia, leukopenia, infection, and hyperlipemia.

Adverse events in heart transplant patients in the European trial are presented in Table 14.

In the US study, mean serum creatinine levels at 1 year post-transplant were significantly lower in the Adoport 5 mg/MMF group compared with those in either the cyclosporine/MMF group (p=0.002, one-way ANOVA) or the Adoport 5 mg/sirolimus group (p=0.02, one-way ANOVA).

Rheumatoid Arthritis: In a long-term study of rheumatoid arthritis patients receiving Adoport 5 mg treatment, the adverse events seen in this patient population were similar in nature to those previously reported for patients receiving liver or kidney transplants. In this study, as well as 2 other studies, the incidence of treatment emergent adverse events seen in the rheumatoid arthritis patient, has a lower incidence of occurrence than seen in the transplant patient.

A summary of treatment-emergent adverse events experienced by at least 5% of patients in any treatment group is presented.

The overall incidence of treatment-emergent adverse events for any treatment group for the 3 studies (RA-001, 049 and 051) ranged from 72-90.6%. In the placebo-controlled studies (RA-001 and 049), the overall incidence of treatment-emergent adverse events for the Adoport 5 mg-treated groups was significantly different from placebo. In the Adoport 5 mg-treated groups, the most common adverse events seen across the 3 studies were flu syndrome, diarrhea, nausea, abdominal pain, dyspepsia and tremor.

In the case of gastrointestinal events, the incidence of diarrhea in the Adoport 5 mg-treated groups in the 3 studies varied from 13-28.1%, with incidence increasing with dose. Adoport 5 mg 5 mg/day in the RA-001 study elicited the highest incidence of diarrhea (28.1%); the next highest incidence of diarrhea was 19.9% in the 3 mg/day group in the 051 study. The incidences of diarrhea in the Adoport 5 mg 5 mg/day group in the RA-001 study, and in the 2 mg and 3 mg groups in the 049 study were significantly different from placebo. Nausea was seen in the Adoport 5 mg-treated groups with incidences of 10.5-18.8%. Only the incidence of nausea in the Adoport 5 mg 3 mg/day group in the RA-001 study was significantly different from placebo, and the incidence did not increase with an increasing dose. Dyspepsia was observed in the Adoport 5 mg-treated groups with incidences of 6.5-20.3%. In the 3 studies, the incidence of dyspepsia in patients taking Adoport 5 mg 3mg/day were 6.5% (049), 13.1% (051), and 20.3% (RA-001). The incidences of dyspepsia in the 2 mg Adoport 5 mg/day group in the 049 study and in the Adoport 5 mg 3 mg/day group in the RA-001 study were significantly different from placebo. No increase in incidence was seen with increasing dose in any study. Abdominal pain was reported in the Adoport 5 mg-treated groups with incidences of 6.5-13.5%. There was no increase in incidence with increasing doses, and there was no significant difference from placebo in either placebo-controlled study.

The incidence of vasodilatation in the Adoport 5 mg-treated groups varied from 1.6-6.3%. There was an increased incidence of vasodilatation with higher doses of Adoport 5 mg. The incidences of vasodilatation in the Adoport 5 mg 3 mg/day group in the 049 study and in the Adoport 5 mg 5 mg/day group in the RA-001 study were significantly different from placebo.

Tremor occurred in the Adoport 5 mg-treated groups with incidences of 3.1-21.9%. The incidence of tremor increased with an increasing dose, and in the Adoport 5 mg 5 mg/day group in the RA-001 study, the incidence of tremor (21.9%) was more than twice the incidence of tremor seen with Adoport 5 mg 3 mg/day in any of the 3 studies. The incidences of tremor in the Adoport 5 mg 3 mg/day group in the 049 study and in the Adoport 5 mg 5 mg/day group in the RA-001 study were significantly different from placebo. Paresthesia was seen in the Adoport 5 mg-treated groups with incidences of 2.6-9.4%. The incidence of paresthesia increased with increasing dose, and in the Adoport 5 mg 5 mg/day group in the RA-001 study, the incidence of paresthesia (9.4%) was more than twice the incidence of tremor seen with Adoport 5 mg 3 mg/day in any of the 3 studies. The incidence of paresthesia in the Adoport 5 mg 5 mg/day group in the RA-001 study was significantly different from placebo.

The incidence of urinary tract infections in the Adoport 5 mg-treated groups varied from 3.2-12.5%. The incidence of urinary tract infection in the Adoport 5 mg 3 mg/day group in the RA-001 study was significantly different from placebo; however, the incidence did not increase with increasing doses. The incidence of flu-like syndrome in the Adoport 5 mg-treated groups ranged from 15.6-26.2%. There was no increase in incidence with larger doses, and no difference from placebo in any Adoport 5 mg-treated group. The incidence of other infections was between 1.6% and 3.3% in the Adoport 5 mg-treated groups. Increasing dose did not influence the incidence of infection, and there was no difference seen from placebo.

Comparisons of patient subpopulations were performed on data from patients in the 051 study, all of whom received Adoport 5 mg 3 mg/day. In general, the incidence of adverse events was similar in patients <65 years of age and ≥65 years of age, in patients with and without hypertension, in patients with and without hyperlipidemia, and in patients with and without diabetes.

A total of 213 patients (23.8%) were at least 65 years of age at study entry. The overall incidence of adverse events for patients ≥65 years of age (86.9%) was similar to that for patients <65 years of age (88.7%). There were no notable differences between patients ≥65 years of age and those <65 years of age for the incidence of any specific adverse events. The more common adverse events occurring in at least 10% of patients ≥65 years of age were flu syndrome (18.3%), diarrhea (16.9%), tremor (15%), nausea (13.6%), headache (12.7%), accidental injury (12.2%), hypertension (12.2%), dyspepsia (11.7%), and abdominal pain (11.3%). For patients <65 years of age, the more common adverse events were occurring in at least 10% of patients were flu-syndrome (28.7%), diarrhea (20.8%), headache (15.8%), nausea (14.9%), abdominal pain (14.2%), and dyspepsia (13.5%). The incidences of tremor, accidental injury, and hypertension among these patients were 9.1%, 7.6%, and 7.3%, respectively.

Three hundred fifty patients (39.1%) had a history of hypertension at the time they entered the study. The overall incidence of adverse events for patients with a history of hypertension (91.1%) was similar to that for patients without a history of hypertension (86.4%). Among adverse events reported for at least 5% of patients with a history of hypertension, the incidences of bronchitis (6.9%) and peripheral edema (6%) were more than twice the incidences (3.1% and 2.4%, respectively) reported for patients without a history of hypertension. The more common adverse events occurring in at least 10% of patients with a history of hypertension were flu-syndrome (26.9%), diarrhea (18.3%), nausea (15.7%), headache (13.4%), dyspepsia (13.1%), tremor (13.1%), abdominal pain (13.1%), and hypertension (11.7%). For patients without a history of hypertension, the more common adverse events occurring in at least 10% of patients were flu-syndrome (25.8%), diarrhea (20.9%), headache (16.1%), nausea (13.9%), abdominal pain (13.7%), and dyspepsia (13.0%). The incidences of tremor and hypertension among these patients were 8.8% and 6.4%, respectively.

A total of 271 patients (30.2%) had a history of hyperlipidemia at the time they entered the study. The overall incidence of adverse events for patients with a history of hyperlipidemia (92.6%) was similar to that for patients without a history of hyperlipidemia (86.4%). There were no notable differences between patients with a history of hyperlipidemia and those without a history of hyperlipidemia for the incidence of any specific adverse events. The more common adverse events occurring in at least 10% of patients with a history of hyperlipidemia were flu-syndrome (26.2%), diarrhea (18.1%), nausea (15.9%), dyspepsia (14.0%), headache (12.9%), tremor (12.2%), abdominal pain (11.8%), and asthenia (10.3%). For patients without a history of hyperlipidemia, the more common adverse events occurring in at least 10% of patients were flu-syndrome (26.2%), diarrhea (20.6%), headache (16.0%), abdominal pain (14.2%), nausea (14.1%), and dyspepsia (12.6%). The incidences of tremor and asthenia among these patients were 9.8% and 7.7%, respectively. Hypercholesterolemia and hyperlipemia were reported as adverse events in 3% and 2.2%, respectively, of patients with a history of hyperlipidemia, and in 1.4% and 1%, respectively, of patients without a history of hyperlipidemia.

Seventy-five patients (8.4%) had a history of diabetes at the time of study entry. The overall incidence of adverse events for patients with a history of diabetes (89.3%) was similar to that for patients without a history of diabetes (88.2%). Among adverse events reported for at least 5% of patients with a history of diabetes, the incidences of urinary tract infection (13.3%), hyperglycemia (9.3%), and infection (8%) were more than twice the incidences (5.2%, 1.8%, and 2.9%, respectively) reported for patients without a history of diabetes, and the incidence of headache (6.7%) in patients with a history of diabetes was less than half the incidence (15.8%) reported for patients without a history of diabetes. The more common adverse events occurring in at least 10% of patients with a history of diabetes were flu-syndrome (26.7%), diarrhea (18.7%), tremor (17.3%), dyspepsia (16%), urinary tract infection (13.3%), nausea (13.3%), and hypertension (12%). The incidences of headache and abdominal pain among these patients were 6.7% and 8% respectively. For patients without a history of diabetes, the more common adverse events occurring in at least 10% of patients were flu-syndrome (26.2%), diarrhea (20%), headache (15.8%), nausea (14.7%), abdominal pain (14%), and dyspepsia (12.8%). The incidences of tremor and urinary tract infection among these patients were 9.9% and 5.2%, respectively.

In some rheumatoid arthritis patients, an increase in serum creatinine levels has been detected. In the long-term safety study (98-0-051), in which patients were treated with Adoport 5 mg for up to 18 months, 65.5% of all patients who had increases in serum creatinine ≥30% to <40% above baseline had levels return to baseline during the study. For the remaining patients, creatinine levels either did not return to baseline or no documentation of follow-up levels was available. Patients with increases in serum creatinine levels, ≥40% above baseline, had their levels return to baseline in 56.3% of all patients. These included patients who continued study drug therapy and patients who discontinued study drug therapy during the recovery period. For those patients whose creatinine levels returned to baseline, the median time to return to baseline creatinine levels was 40.5 days for patients with ≥30% to <40% increase from baseline and 32 days for patient with ≥40% increases from baseline.

In Study FK506RA-001, patients who experienced an increase from baseline in serum creatinine levels of ≥30% and <40%, 50% of the patients in the placebo group, 80% of patients in the Adoport 5 mg 1 mg treatment group, 89% in the Adoport 5 mg 3 g treatment group and 78% patients in the Adoport 5 mg 5 mg treatment group experienced a return to baseline serum creatinine levels within 56 days for placebo-treated patients, 33 days for patients treated with Adoport 5 mg 1 mg, 29 days for those treated with 3 mg and 57 days for those treated with 5 mg.

In those patients experiencing a serum creatinine increase of ≥40%, above baseline, 50% of placebo-treated patients, 20% of the 1 mg treated patents, 75% of the patients treated with Adoport 5 mg 3 mg and 31% of patients treated with Adoport 5 mg 5 mg experienced a subsequent return to baseline creatinine levels. The duration of time for serum creatinine levels to return to baseline for this patient population occurred sooner than those patients experiencing a serum creatinine increase of ≥30% and <40%. Patients treated with placebo demonstrated a return to baseline of serum creatinine levels within 28 days, an average of 6 days for patients treated with 1 mg, 20 days for those treated with 3 mg and 38 days for those treated with 5 mg. There were however, 8 of 9 patients with elevated creatinine levels (>40%) who discontinued the study. These patients had creatinine values return to below a 40% increase from baseline and within normal limits (0.7-1.4 mg/dL) post discontinuation, with 1 patient lost to follow-up.

In study 98-0-049, of those patients who experienced an increase from baseline in creatinine of ≥30 to <40%, 63.6% of these patients in the placebo-treatment group, 50% of patients in the Adoport 5 mg 2 mg treatment group, and 77.8% of patients in the Adoport 5 mg 3 mg treatment group, experienced a documented subsequent return to baseline creatinine values, within 36 days for placebo-treated patients, 43 days for 2 mg treated patients and 41 days for 3 mg patients treated with Adoport 5 mg. For those patients with a ≥40% increase from baseline, 33.3% of patients in the placebo treatment group, 53.3% of patients in the Adoport 5 mg 2 mg treatment group, and 45.5% of patients in the Adoport 5 mg 3 mg treatment group experienced a documented subsequent return to baseline creatinine values. Serum creatinine levels in this patient population returned to baseline levels sooner, than patients who experienced an increase from baseline of ≥30% to <40%. Patients with a serum creatinine increase >40% demonstrated a return to baseline at 20 days for placebo treated patients, 33 days for patients treated with 2 mg and 38 days for those patients treated with Adoport 5 mg 3 mg per day. The remaining patients either had creatinine levels that did not return to baseline during the follow-up period or were not monitored for return to baseline values.

For 88.5% (139/157) of placebo-treated patients, 87% (134/154) of patients treated with Adoport 5 mg 2 mg/day and 86.3% (132/153) of patients treated with Adoport 5 mg 3 mg/day, creatinine levels were within the normal range at baseline, and remained within the normal range throughout the study. In total, 4 patients all treated with 3 mg Adoport 5 mg, discontinued treatment as a result of a reported adverse event of increased serum creatinine.

Less Common Clinical Trial Adverse Drug Reactions: The following adverse events were reported in either liver kidney, and/or heart transplant recipients who were treated with Adoport 5 mg in clinical trials.

Nervous System : Abnormal dreams, agitation, amnesia, anxiety, confusion, convulsion, crying, depression, dizziness, elevated mood, emotional lability, encephalopathy, haemorrhagic stroke, hallucinations, headache, hypertonia, incoordination, insomnia, monoparesis, myoclonus, nerve compression, neuralgia, neuropathy, paresthesia, paralysis flaccid, impaired psychomotor skills, psychosis, quadriparesis, somnolence, abnormal thinking, vertigo, impaired writing.

Special Senses: Abnormal vision, amblyopia, ear pain, otitis media, tinnitus.

Gastrointestinal: Anorexia, cholangitis, cholestatic jaundice, duodenitis, dyspepsia, dysphagia, esophagitis, flatulence, gastritis, gastroesophagitis, gastrointestinal (GI) hemorrhage, increased GGT, GI disorder, GI perforation, hepatitis, hepatitis granulomatous, ileus, increased appetite, jaundice, liver damage, abnormal liver function test, esophagitis ulcerative, oral monoiliasis, pancreatic pseudocyst, rectal disorder, stomatitis.

Cardiovascular: Abnormal electrocardiogram (ECG), angina pectoris, arrhythmia, atrial fibrillation, atrial flutter, bradycardia, cardiac fibrillation, cardiopulmonary failure, cardiovascular disorder, chest pain, congestive heart failure, deep thrombophlebitis, echocardiogram abnormal, abnormal electrocardiogram QRS complex, abnormal electrocardiogram ST segment, heart failure, decreased heart rate, hemorrhage, hypotension, peripheral vascular disorder, phlebitis, postural hypotension, syncope, tachycardia, thrombosis, vasodilatation.

Urogenital : Acute kidney failure, albuminuria, BK virus nephropathy, bladder spasms, cystitis, dysuria, hematuria, hydronephrosis, kidney failure, kidney tubular necrosis, nocturia, oliguria, pyuria, toxic nephropathy, urge incontinence, urinary frequency, urinary tract infection, urinary incontinence, urinary retention, vaginitis.

Metabolic/Nutritional: Acidosis, increased alkaline phosphatase, alkalosis, increased AST (SGOT), increased ALT (SGPT), decreased bicarbonate, bilirubinemia, increased BUN, dehydration, edema, increased GGT, gout, abnormal healing, hypercalcemia, hypercholesterolemia, hyperlipemia, hypertriglyceridemia, hyperphosphatemia, hyperuricemia. hypervolemia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, hypophosphatemia, hypoproteinemia, increase lactic dehydrogenase, weight gain.

Endocrine System : Diabetes mellitus, Cushing’s syndrome.

Hemic/Lymphatic: Coagulation disorder, ecchymosis, increased haematocrit, abnormal haemoglobin, hypochromic anemia, leukocytosis, leukopenia, polycythemia, decreased prothrombin, decreased serum iron, thrombocytopenia.

Body as a Whole: Enlarged abdomen, abscess, accidental injury, allergic reaction, back pain, cellulitis, chills, fall, abnormal feeling, flu-syndrome. generalized edema, hernia, decreased mobility, pain, peritonitis, photosensitivity reaction, sepsis, temperature intolerance, ulcer.

Musculoskeletal: Arthralgia, cramps, generalized spasm, joint disorder, leg cramps, myalgia, myasthenia, osteoporosis.

Respiratory System: Asthma, bronchitis, increased cough, emphysema, hiccups, lung disorder, decreased lung function, pharyngitis, pneumonia, pneumothorax, pulmonary edema, respiratory disorder, rhinitis, sinusitis, voice alteration.

Skin and Appendage: Acne, alopecia, exfoliative dermatitis, fungal dermatitis, herpes simplex, herpes zoster, hirsutism, pruritus, rash, neoplasm skin benign, skin discoloration, skin disorder, skin ulcer, sweating.

The following nervous system adverse events were also reported at a frequency (<3%): Acute brain syndrome (0.2%), coma (2.1%), delirium (1.2%), dysarthria (0.4%), dystonia (0.4%), encephalopathy (2.5%), flaccid paralysis (0.4%), hemiplegia (0.8%), nystagmus (0.8%), paralysis (0.4%) and stupor (0.2%).

Abnormal Hematologic and Clinical Chemistry Findings: Refer to Precautions (Hepatic, Renal, and Monitoring and Laboratory Tests).

Post Marketing Adverse Drug Reactions: The following adverse events have been reported from worldwide marketing experience with Adoport 5 mg. Because these events are reported voluntarily from a population of uncertain size, are associated with concomitant diseases and multiple drug therapies and surgical procedures, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Decisions to include these events in labeling are typically based on ≥1 of the following factors: Seriousness of the event, frequency of the reporting, or strength of causal connection to the drug.

Cardiovascular: Cardiac arrhythmia, cardiac arrest, abnormal electrocardiogram T wave, flushing, myocardial infarction, myocardial ischaemia, QT prolongation with or without Torsade de Pointes, venous thrombosis deep limb, ventricular extrasystoles, ventricular fibrillation.

Gastrointestinal: Bile duct stenosis, colitis, enterocolitis, gastrooesophageal reflux disease, hepatic cytolysis, hepatic necrosis, hepatotoxicity, impaired gastric emptying, liver fatty, mouth ulceration, pancreatitis haemorrhagic, pancreatitis necrotizing, stomach ulcer, venoocclusive liver disease

Hemic/Lymphatic: Agranulocytosis, disseminated intravascular coagulation, hemolytic anemia, neutropenia, pancytopenia, pure red cell aplasia, thrombocytopenic purpura, thrombotic thrombocytopenic purpura.

Metabolic/Nutritional: Glycosuria, increased amylase including pancreatitis, decreased weight.

Miscellaneous: Feeling hot and cold, feeling jittery, hot flushes, multi-organ failure, primary graft dysfunction.

Nervous System: Carpal-tunnel syndrome, cerebral infarction, hemiparesis. leukoencephalopathy, mental disorder, mutism, posterior reversible encephalopathy syndrome (PRES), progressive multifocal leukoencephalopathy (PML), quadriplegia, speech disorder, polyneuropathy, neuropathy peripheral, peripheral sensory neuropathy, mononeuropathy multiplex.

Respiratory: Acute respiratory distress syndrome, interstitial lung disease (predominantly in rheumatoid arthritis), lung infiltration, respiratory distress, respiratory failure.

Skin: Stevens-Johnson syndrome, toxic epidermal necrolysis.

Special Senses: Blindness, blindness cortical, hearing loss including deafness, photophobia.

Urogential: Acute renal failure, haemorrhagic cystitis, hemolytic-uremic syndrome, micturition disorder.

There have been rare spontaneous reports of myocardial hypertrophy associated with clinically manifested dysfunction in patients receiving Adoport 5 mg therapy.

Adoport 5 mg contraindications

See also:
What is the most important information I should know about Adoport 5 mg?

Adoport 5 mg capsules are contraindicated in patients with a hypersensitivity to Adoport 5 mg. Adoport 5 mg injection is contraindicated in patients with a hypersensitivity to HCO-60 (polyoxyl 60 hydrogenated castor oil). Hypersensitivity symptoms reported include dyspnea, rash, pruritus, and acute respiratory distress syndrome.

Active ingredient matches for Adoport 5 mg:

Tacrolimus in France, Turkey, United Kingdom.


List of Adoport 5 mg substitutes (brand and generic names)

Sort by popularity
Unit description / dosage (Manufacturer)Price, USD
Capsule, Extended Release; Oral; Tacrolimus 0.5 mg (Astellas Pharma)
Capsule, Extended Release; Oral; Tacrolimus 1 mg (Astellas Pharma)
Capsule, Extended Release; Oral; Tacrolimus 3 mg (Astellas Pharma)
Capsule, Extended Release; Oral; Tacrolimus 5 mg (Astellas Pharma)
0.5 mg x 10's (Astellas Pharma)
1 mg x 10's (Astellas Pharma)
5 mg x 10's (Astellas Pharma)
Advagraf 0.5 mg x 50's (Astellas Pharma)
Advagraf 1 mg x 50's (Astellas Pharma)
Advagraf 5 mg x 50's (Astellas Pharma)
Advagraf 0.5 mg x 1000's (Astellas Pharma)
Advagraf 1 mg x 1000's (Astellas Pharma)
Advagraf 5 mg x 1000's (Astellas Pharma)
Advagraf 0.5 mg x 5 x 10's (Astellas Pharma)
Advagraf 1 mg x 5 x 10's (Astellas Pharma)
Capsules, Extended Release; Oral; Tacrolimus 0.5 mg (Astellas Pharma)
Capsules, Extended Release; Oral; Tacrolimus 1 mg (Astellas Pharma)
Capsules, Extended Release; Oral; Tacrolimus 3 mg (Astellas Pharma)
Capsules, Extended Release; Oral; Tacrolimus 5 mg (Astellas Pharma)
Advagraf 0.5mg CAP / 10 (Astellas Pharma)
Advagraf 1mg CAP / 10 (Astellas Pharma)
Advagraf 5mg CAP / 10 (Astellas Pharma)
Advagraf PR cap 0.5 mg 50's (Astellas Pharma)
Advagraf PR cap 1 mg 50's (Astellas Pharma)
Advagraf PR cap 5 mg 50's (Astellas Pharma)
ADVAGRAF modified-release cap 0.5 mg x 10's (Astellas Pharma)
ADVAGRAF modified-release cap 1 mg x 10's (Astellas Pharma)$ 12.05
ADVAGRAF modified-release cap 5 mg x 10's (Astellas Pharma)
Advagraf PR hard cap 0.5 mg 5 x 10's (Astellas Pharma)
Advagraf PR hard cap 1 mg 5 x 10's (Astellas Pharma)
Advagraf capsule / extended release 1 mg (Astellas Pharma)
Advagraf Prolonged release hard capsules 1 mg (Astellas Pharma)
Advagraf Prolonged release hard capsules 3 mg (Astellas Pharma)
Advagraf Prolonged release hard capsules 5 mg (Astellas Pharma)
Advagraf Prolonged release hard capsules 0.5 mg (Astellas Pharma)
Advagraf capsule / extended release 5 mg (Astellas Pharma)
Advagraf capsule / extended release 3 mg (Astellas Pharma)
Advagraf capsule / extended release 0.5 mg (Astellas Pharma)

References

  1. DailyMed. "TACROLIMUS: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. PubChem. "tacrolimus". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. DrugBank. "tacrolimus". http://www.drugbank.ca/drugs/DB00864 (accessed September 17, 2018).

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