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
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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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.
Adoport 5 mg ointment comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Adoport 5 mg ointment refilled.
Adoport 5 mg ointment is for external use only. Do not get Adoport 5 mg ointment in your eyes, nose, or mouth.
Dry your skin completely after a bath or shower before applying Adoport 5 mg ointment.
Wash your hands before using Adoport 5 mg ointment.
Apply a thin layer of Adoport 5 mg ointment to the affected area only. Use the smallest amount needed to control your condition. Gently rub the medicine in until it is evenly distributed. Wash your hands after applying Adoport 5 mg ointment (if hands are not an area of treatment).
If you are a caregiver applying Adoport 5 mg ointment to someone else's skin, wash your hands with soap and water after applying Adoport 5 mg ointment.
Do not bathe, shower, or swim right after applying Adoport 5 mg ointment. This could wash off the ointment.
Do not cover the treated area with bandages or other dressings or wraps, unless otherwise directed by your doctor.
Stop using Adoport 5 mg ointment when the signs and symptoms of the condition (eg, itching, rash, redness) go away, unless your doctor directs you otherwise.
If you miss a dose of Adoport 5 mg ointment, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.
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
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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This form of Adoport 5 mg is used on the skin to treat a skin condition called eczema (atopic dermatitis) in patients who have not responded well to (or should not use) other eczema medications.
Eczema is an allergic-type condition that causes red, irritated, and itchy skin. This drug works by weakening the skin's defense (immune) system, thereby decreasing the allergic reaction and relieving the eczema. Adoport 5 mg belongs to a class of drugs known as topical calcineurin inhibitors (TCIs).
This medication is not recommended if you have a history of a certain rare genetic disorder (Netherton's syndrome). Also, this medication should not be used by anyone who has a weakened immune system (e.g., following an organ transplant).
How to use Adoport 5 mg topical
Read the Medication Guide provided by your pharmacist before you start using Adoport 5 mg and each time you get a refill. If you have any questions, consult your doctor or pharmacist.
Wash your hands with soap and water before using this medication. Apply a thin layer to the affected areas of skin, usually twice daily or as directed by your doctor. Rub the medication into the skin gently and completely. Wash your hands after using this product unless your hands are being treated. If your doctor recommends a moisturizer, apply it after this medication.
This product is for use on the skin only. Avoid getting this medication in your eyes or on the inside of your nose or mouth. If you do get the medication in those areas, flush with plenty of water. Do not apply this medication to open wounds or infected areas. Do not cover the treated area with plastic or waterproof bandages unless directed to do so by your doctor. Do not bathe, shower, or swim right after applying this medication. This could wash it off the treated area.
Use this medication exactly as directed. Your doctor may instruct you to stop using it once your eczema has cleared and to start using it again if symptoms reappear. Consult your doctor for details.
Inform your doctor if your condition does not improve after 6 weeks of using this medication or if your condition worsens at any time.
Only the weakest product should be used in children 2 to 15 years old.
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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Adoport 5 mg Dosage
Generic name: Adoport 5 mg 0.75mg
Dosage form: tablet, extended release
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
Administration Instructions
Take Adoport 5 mg on an empty stomach at the same time of the day, preferably in the morning (to ensure consistent and maximum possible drug exposure).
Swallow Adoport 5 mg whole with fluid (preferably water); do not chew, divide, or crush the tablets.
If a dose is missed, take it as soon as possible within 15 hours after missing the dose; beyond the 15-hour time frame, wait until the usual scheduled time to take the next regular daily dose. Do not double the next dose.
Avoid eating grapefruit or drinking grapefruit juice or alcoholic beverage while taking Adoport 5 mg.
African-American patients, compared to Caucasian patients, may need to be titrated to higher Adoport 5 mg dosages to attain comparable trough concentrations.
Conversion from Adoport 5 mg Immediate-Release Formulations
To convert from a Adoport 5 mg immediate-release product to Adoport 5 mg, administer an Adoport 5 mg once daily dose that is 80% of the total daily dose of the Adoport 5 mg immediate-release product. Monitor Adoport 5 mg whole blood trough concentrations and titrate Adoport 5 mg dosage to achieve target whole blood trough concentration ranges of 4 to 11 ng/mL.
Therapeutic Drug Monitoring
Measure Adoport 5 mg whole blood trough concentrations at least two times on separate days during the first week after initiation of dosing and after any change in dosage, after a change in co-administration of CYP3A inducers and/or inhibitors, or after a change in renal or hepatic function. When interpreting measured concentrations, consider that the time to achieve Adoport 5 mg steady state is approximately 7 days after initiating or changing the Adoport 5 mg dose.
Monitor Adoport 5 mg whole blood trough concentrations using a validated assay [e.g., immunoassays or high-performance liquid chromatography with tandem mass spectrometric detection (HPLC/MS/MS)]. The immunosuppressive activity of Adoport 5 mg is mainly due to the parent drug rather than to its metabolites. Immunoassays may react with metabolites as well as the parent drug. Therefore, whole blood Adoport 5 mg trough concentrations obtained with immunoassays may be numerically higher than concentrations obtained with an assay using HPLC/MS/MS. Comparison of the whole blood Adoport 5 mg trough concentrations of patients to those described in the prescribing information and other published literature must be made with knowledge of the assay method(s) employed.
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.
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 USstudy, 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.
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.
There have been rare spontaneous reports of myocardial hypertrophy associated with clinically manifested dysfunction in patients receiving Adoport 5 mg therapy.
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.
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).
The results of a survey conducted on ndrugs.com for Adoport 5 mg are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Adoport 5 mg. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
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