Caretropin Uses

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What is Caretropin?

Caretropin (Caretropin) is a form of human growth hormone important for the growth of bones and muscles. It is similar to the growth hormone your body manufactures.

Caretropin is used to treat Short Bowel Syndrome (SBS) in patients who are on a specialized diet.

When used with along with special diet, Caretropin helps your bowel take in more water, electrolytes and nutrients and lowers the need for I.V. (intravenous) feedings.

Caretropin is not cure for Short Bowel Syndrome.

Caretropin 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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Pediatric Patients

Caretropin (Caretropin [rDNA origin] for injection) is indicated for the treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone.

Caretropin (Caretropin [rDNA origin] for injection) is indicated for the treatment of pediatric patients who have growth failure due to Prader-Willi syndrome (PWS). The diagnosis of PWS should be confirmed by appropriate genetic testing.

Caretropin (Caretropin [rDNA origin] for injection) is indicated for the treatment of growth failure in children born small for gestational age (SGA) who fail to manifest catch-up growth by age 2 years.

Caretropin (Caretropin [rDNA origin] for injection) is indicated for the treatment of growth failure associated with Turner syndrome.

Caretropin (Caretropin [rDNA origin] for injection) is indicated for the treatment of idiopathic short stature (ISS), also called non-growth hormone-deficient short stature, defined by height standard deviation score (SDS) < -2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range, in pediatric patients whose epiphyses are not closed and for whom diagnostic evaluation excludes other causes associated with short stature that should be observed or treated by other means.

Adult Patients

Caretropin (Caretropin [rDNA origin] for injection) is indicated for replacement of endogenous growth hormone in adults with growth hormone deficiency who meet either of the following two criteria:

Adult Onset (AO)

Patients who have growth hormone deficiency, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; or

Childhood Onset (CO)

Patients who were growth hormone deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes.

Patients who were treated with Caretropin for growth hormone deficiency in childhood and whose epiphyses are closed should be reevaluated before continuation of Caretropin therapy at the reduced dose level recommended for growth hormone deficient adults. According to current standards, confirmation of the diagnosis of adult growth hormone deficiency in both groups involves an appropriate growth hormone provocative test with two exceptions: (1) patients with multiple other pituitary hormone deficiencies due to organic disease; and (2) patients with congenital/genetic growth hormone deficiency.

How should I use Caretropin?

Use Caretropin 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 Caretropin.

Uses of Caretropin 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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Various brands of this medication are used for the treatment of one of the following medical conditions: growth failure, growth hormone deficiency, intestinal disorder (short bowel syndrome) or HIV-related weight loss or wasting.

Caretropin is also used to increase height in children with certain genetic disorders (such as Noonan syndrome, Turner's syndrome).

How to use Caretropin subcutaneous

Read the Patient Information Leaflet that may come with your brand of this medication provided by your pharmacist before you start using Caretropin and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Some brands of this medication are given by injection into a muscle or under the skin. Some brands may only be injected under the skin. The way you inject this medicine will depend on the brand that you are using. Check with your pharmacist to ensure that the way you are injecting your medicine is correct. It is important to change the location of the injection site to avoid problem areas under the skin. For best results, this medication must be used exactly as prescribed by your doctor. It is important to understand your therapy and to follow your doctor's instructions closely.

The dosage is based on your age, weight, medical condition and response to treatment.

If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Do not shake while mixing the solution. Shaking makes the medication not work properly. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.

If this medicine is used for short bowel syndrome, consult your doctor if a special diet (high carbohydrate/low-fat) or the use of nutritional supplements may be helpful.

If this medicine is used for weight loss/muscle wasting, it may take up to 2 weeks to notice the effects of the drug. Do not use more of this medication than prescribed or use it more often since the risk of side effects will be increased.

Caretropin description

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Each cartridge contains Somatropin (recombinant human growth hormone) 5.83 mg/mL (6 mg/1.03 mL) and 8 mg/mL (12 mg/1.5 mL), respectively. It also contains the following excipients: Sucrose, poloxamer 188, phenol, citric acid and citrate buffer.

Each vial of Caretropin 3.33 mg contains Somatropin (recombinant human growth hormone) accompanied by a vial of diluent containing saline 5 mL with benzyl alcohol (0.9% w/v sodium chloride and 0.9% w/v benzyl alcohol).

Each click.easy vial contain Caretropin (recombinant human growth hormone). Caretropin is produced by recombinant deoxyribonucleic acid technology in mammalian cells.

Reconstitution with the content of the bacteriostatic solvent cartridge gives a concentration of 5.83 mg/mL.

Caretropin 6-mg and 8-mg is clear to slightly opalescent solution with pH of 5.6-6.6 and osmolality 250-450 mOsm/kg.

Caretropin dosage

The Caretropin (Caretropin (rdna origin) for inj) dosage and administration schedule should be individualized for each patient. Response to GH therapy in pediatric patients tends to decrease over time. However in pediatric patients, failure to increase growth rate, particularly during the first year of therapy, suggests the need for close assessment of compliance and evaluation of other causes of growth failure, such as hypothyroidism, undernutrition, and advanced bone age.

Once-Monthly Injection - It is recommended that an SC injection at a dosage of 1.5 mg/kg body weight be administered on the same day of each month. Dosages above the recommended once-monthly regimen have not been studied in clinical trials. Note: subjects over 15 kg will require more than one injection per dose.

Twice-Monthly Injections - It is recommended that an SC injection at a dosage of 0.75 mg/kg body weight be administered twice each month on the same days of each month (e.g., Days 1 and 15 of each month). Dosages above the recommended twice-monthly regimen have not been studied in clinical trials. Note: subjects over 30 kg will require more than one injection per dose.

The table below indicates the required number of injections per dose.

Patient Weight (kg) Number of Injections Per Dose
0.75 mg/kg twice monthly 1.5 mg/kg once monthly
≤ 15 1 1
> 15-30 1 2
> 30-45 2 3
> 45-60 2 *
> 60 3 *
*Twice-monthly dosing recommended

Preparation of Dose

Caretropin (Caretropin (rdna origin) for inj) powder may only be suspended in Diluent for Caretropin supplied in the kit and administered with the supplied needles.

1. Using the chart below, determine the volume of diluent needed to suspend Caretropin (Caretropin (rdna origin) for inj). Withdraw the diluent into a 3 cc syringe using the needle supplied in the kit. Only the diluent supplied in the kit should be used for reconstitution, and any remaining diluent should be discarded.

Vial Size (mg Caretropin) Volume of Diluent to Be Added (mL)
13.5 0.8
18 1.0
22.5 1.2

Note: Since the suspension is viscous and prevents complete withdrawal of the entire vial contents, the vials are overfilled to ensure delivery of the labeled amount of Caretropin. Using these diluent volumes for final suspension results in a final concentration of 19 mg/mL Caretropin in each vial size.

2. Inject the diluent into the vial against the vial wall. Swirl the vial vigorously for up to 2 minutes to disperse the powder in the diluent. Mixing is complete when the suspension appears uniform, thick, and milky, and all the powder is fully dispersed. Do not store the vial after reconstitution or the suspension may settle.

3. Withdraw the required dose. Only one vial should be used for each injection. Replace the needle with a new needle from the kit and administer the dose immediately to avoid settling of the suspension in the syringe. Deliver the dose from the syringe at a continuous rate over not more than 5 seconds. Discard unused vial contents as the product contains no preservative. An extra needle has been provided in the kit.

Stability and Storage

Before Suspension - Caretropin (Caretropin (rdna origin) for inj) and diluent vials must be stored at 2-8°C/36-46°F (under refrigeration). Avoid freezing the vials of Caretropin (Caretropin (rdna origin) for inj) and Diluent for Caretropin (Caretropin (rdna origin) for inj). Do not expose the Caretropin (Caretropin (rdna origin) for inj) vial to temperatures above 25°C (77°F). Expiration dates are stated on the labels.

After Suspension - Because Caretropin (Caretropin (rdna origin) for inj) contains no preservatives, all injections must be given immediately. Do not allow the suspension to settle prior to withdrawal of the dose. Suspended solution cannot be stored or used to suspend another vial of Caretropin (Caretropin (rdna origin) for inj).

How supplied

Caretropin (Caretropin (rdna origin) for inj) is supplied as single-use vials with 13.5 mg, 18 mg, or 22.5 mg sterile, preservative-free Caretropin powder per vial.

Each 13.5 mg kit contains one single-use 13.5 mg vial of Caretropin® [Caretropin (rDNA origin) for injectable suspension], one 1.5 mL single-use vial of Diluent for Caretropin (Caretropin (rdna origin) for inj), and three 21-gauge, 1/2" needles: NDC 50242-032-35.

Each 18 mg kit contains one single-use 18 mg vial of Caretropin® [Caretropin (rDNA origin) for injectable suspension], one 1.5 mL single-use vial of Diluent for Caretropin (Caretropin (rdna origin) for inj), and three 21-gauge, 1/2" needles: NDC 50242-034-41.

Each 22.5 mg kit contains one single-use 22.5 mg vial of Caretropin® [Caretropin (rDNA origin) for injectable suspension], one 1.5 mL single-use vial of Diluent for Caretropin (Caretropin (rdna origin) for inj), and three 21-gauge, 1/2" needles: NDC 50242-036-54.

Caretropin™ [Caretropin (rDNA origin) for injectable suspension] and Diluent for Caretropin (Caretropin (rdna origin) for inj) are manufactured for: Genentech, Inc. 1 DNA Way, South San Francisco, CA 94080-4990.

Caretropin interactions

See also:
What other drugs will affect Caretropin?

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11β-Hydroxysteroid Dehydrogenase Type 1

The microsomal enzyme 11β-hydroxysteroid dehydrogenase type 1 (11βHSD-1) is required for conversion of cortisone to its active metabolite, cortisol, in hepatic and adipose tissue. GH and Caretropin inhibit 11βHSD-1. Consequently, individuals with untreated GH deficiency have relative increases in 11βHSD-1 and serum cortisol. Introduction of Caretropin treatment may result in inhibition of 11βHSD-1 and reduced serum cortisol concentrations. As a consequence, previously undiagnosed central (secondary) hypoadrenalism may be unmasked and glucocorticoid replacement may be required in patients treated with Caretropin. In addition, patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses following initiation of Caretropin treatment; this may be especially true for patients treated with cortisone acetate and prednisone since conversion of these drugs to their biologically active metabolites is dependent on the activity of 11βHSD-1.

Pharmacologic Glucocorticoid Therapy And Supraphysiologic Glucocorticoid Treatment

Pharmacologic glucocorticoid therapy and supraphysiologic glucocorticoid treatment may attenuate the growth promoting effects of Caretropin in children. Therefore, glucocorticoid replacement dosing should be carefully adjusted in children receiving concomitant Caretropin and glucocorticoid treatments to avoid both hypoadrenalism and an inhibitory effect on growth.

Cytochrome P450-Metabolized Drugs

Limited published data indicate that Caretropin treatment increases cytochrome P450 (CP450)-mediated antipyrine clearance in man. These data suggest that Caretropin administration may alter the clearance of compounds metabolized by CP450 liver enzymes (e.g., corticosteroids, sex steroids, anticonvulsants, cyclosporine). Therefore, careful monitoring is advised when Caretropin is administered in combination with drugs metabolized by CP450 liver enzymes. However, formal drug interaction studies have not been conducted.

Oral Estrogen

Because oral estrogens may reduce the serum IGF-I response to Caretropin treatment, girls and women receiving oral estrogen replacement may require greater Caretropin dosages.

Insulin And/Or Other Hypoglycemic Agents

Patients with diabetes mellitus who receive concomitant treatment with Caretropin may require adjustment of their doses of insulin and/or other hypoglycemic agents.

Drug Abuse And Dependence

Inappropriate use of Caretropin by individuals who do not have indications for which Caretropin is approved, may result in significant negative health consequences. Caretropin is not a drug of dependence.

Caretropin side effects

See also:
What are the possible side effects of Caretropin?

As with all protein pharmaceuticals, patients may develop antibodies to the protein. GH antibody-binding capacities below 2 mg/L have not been associated with growth attenuation. In some cases when binding capacity exceeds 2 mg/L, growth attenuation has been observed. In clinical studies of pediatric patients who were treated with Caretropin (Caretropin (rdna origin) for inj), 0/138 patients with GHD screened for antibody production developed antibodies with binding capacities ≥ 2 mg/L at any time during a treatment period of up to 17.4 months.

In addition to an evaluation of compliance with the prescribed treatment program and thyroid status, testing for antibodies to GH should be carried out in any patient who fails to respond to therapy.

In studies involving 138 pediatric patients treated with Caretropin (Caretropin (rdna origin) for inj), the most frequent adverse reactions were injection-site reactions, which occurred in nearly all patients. On average, 2 to 3 injection-site adverse reactions were reported per injection. These reactions included nodules (61% of injections), erythema (53%), pain post-injection (47%), pain during injection (43%), bruising (20%), itching (13%), lipoatrophy (13%), and swelling or puffiness (8%). The intensity of these reactions was generally rated mild to moderate, with pain during injection occasionally rated as severe (7%).

Adverse reactions observed less frequently in the Caretropin (Caretropin (rdna origin) for inj) studies which were considered possibly, probably, or definitely related to the drug by the treating physician (usually occurring 1–3 days postdose) included: headache (13% of subjects), nausea (8%), lower extremity pain (7%), fever (7%), and vomiting (5%). These symptoms were generally self-limited and well-tolerated. One patient experienced a generalized body rash that was most likely an allergic reaction to Caretropin (Caretropin (rdna origin) for inj).

Leukemia has been reported in a small number of GHD patients treated with GH. It is uncertain whether this increased risk is related to the pathology of GH deficiency itself, GH therapy, or other associated treatments such as radiation therapy for intracranial tumors. On the basis of current evidence, experts cannot conclude that GH therapy is responsible for these occurrences.

Other adverse drug reactions that have been reported in GH-treated patients include the following: 1) Metabolic: mild, transient peripheral edema; 2) Musculoskeletal: arthralgia, carpal tunnel syndrome; 3) Skin: rare increased growth of pre-existing nevi; patients should be monitored for malignant transformation; 4) Endocrine: gynecomastia; and 5) Rare pancreatitis. Of these reactions, only edema ( < 1% of patients) and arthralgia (4%) were reported as related to drug in the Caretropin (Caretropin (rdna origin) for inj) studies.

Caretropin contraindications

See also:
What is the most important information I should know about Caretropin?

Acute Critical Illness

Treatment with pharmacologic amounts of Caretropin is contraindicated in patients with acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure. Two placebo-controlled clinical trials in non-growth hormone deficient adult patients (n=522) with these conditions in intensive care units revealed a significant increase in mortality (41.9% vs. 19.3%) among Caretropin-treated patients (doses 5.3-8 mg/day) compared to those receiving placebo.

Prader-Willi Syndrome in Children

Caretropin is contraindicated in patients with Prader-Willi syndrome who are severely obese or have severe respiratory impairment. There have been reports of sudden death when Caretropin was used in such patients. Caretropin® is not indicated for the long term treatment of pediatric patients who have growth failure due to genetically confirmed Prader-Willi syndrome.

Active Malignancy

In general, Caretropin is contraindicated in the presence of active malignancy. Any pre-existing malignancy should be inactive and its treatment complete prior to instituting therapy with Caretropin. Caretropin should be discontinued if there is evidence of recurrent activity. Since growth hormone deficiency may be an early sign of the presence of a pituitary tumor (or, rarely, other brain tumors), the presence of such tumors should be ruled out prior to initiation of treatment. Caretropin should not be used in patients with any evidence of progression or recurrence of an underlying intracranial tumor.

Diabetic Retinopathy

Caretropin is contraindicated in patients with active proliferative or severe non-proliferative diabetic retinopathy.

Closed Epiphyses

Caretropin should not be used for growth promotion in pediatric patients with closed epiphyses.

Hypersensitivity

Caretropin® is contraindicated in patients with a known hypersensitivity to Caretropin or any of its excipients. Localized reactions are the most common hypersensitivity reactions.

Caretropin® reconstituted with Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol) should not be administered to patients with a known sensitivity to Benzyl Alcohol.



Active ingredient matches for Caretropin:

Somatropin in Philippines.


List of Caretropin substitutes (brand and generic names)

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Unit description / dosage (Manufacturer)Price, USD
Injectable; Injection; Somatropin recombinant 4.8 mg
Injectable; Injection; Somatropin 4 IU
Injectable; Injection; Somatropin recombinant 5.8 mg (P. Upjohn)
Injectable; Injection; Somatropin recombinant 13.8 mg (P. Upjohn)
GENOTROPIN Injection / 16 i.u. / 1 vial units (P. Upjohn)$ 102.38
Genotropin 4iu INJ (P. Upjohn)$ 24.60
Genotropin 12iu16 INJ (P. Upjohn)$ 79.37
Genotropin 16iu INJ (P. Upjohn)$ 101.59
Genotropin 36iu INJ (P. Upjohn)$ 209.52
Genotropin 16 IU/1 mL x 1's (P. Upjohn)$ 179.60
Genotropin 16 IU x 5's (P. Upjohn)
4 IU (P. Upjohn)$ 24.60
12 IU (P. Upjohn)$ 79.37
16 IU (P. Upjohn)$ 101.59
36 IU (P. Upjohn)$ 209.52
Genotropin / two-compartment cartridge 16 IU x 5's (P. Upjohn)
Genotropin / two-chamber 5.3 mg x 5's (P. Upjohn)
Genotropin 12 mg x 5's (P. Upjohn)
Genotropin / two-compartment 5.3 mg x 1's (P. Upjohn)
Genotropin 4 IU INJ (P. Upjohn)$ 24.60
Genotropin 12 IU INJ (P. Upjohn)$ 79.37
Genotropin 16 IU INJ (P. Upjohn)$ 101.59
Genotropin 36 IU INJ (P. Upjohn)$ 209.52
GENOTROPIN 16 IU INJECTION 1 vial / 1 injection each (P. Upjohn)$ 220.11
GENOTROPIN 36 IU INJECTION 1 vial / 1 ML injection each (P. Upjohn)$ 219.20
Genotropin 16IU Injection (P. Upjohn)$ 220.11
Genotropin 36IU Injection (P. Upjohn)$ 219.20
Injectable; Injection; Somatropin 16 IU / ml
Injectable; Injection; Somatropin 32 IU / ml
Injectable; Injection; Somatropin 36 IU / ml
Injectable; Injection; Somatropin 4 IU / ml
Injectable; Injection; Somatropin recombinant 0.2 mg
Injectable; Injection; Somatropin recombinant 0.4 mg
Injectable; Injection; Somatropin recombinant 0.6 mg
Injectable; Injection; Somatropin recombinant 0.8 mg
Injectable; Injection; Somatropin recombinant 1 mg
Injectable; Injection; Somatropin recombinant 1.2 mg
Injectable; Injection; Somatropin recombinant 1.4 mg
Injectable; Injection; Somatropin recombinant 1.6 mg
Injectable; Injection; Somatropin recombinant 1.8 mg
Injectable; Injection; Somatropin recombinant 2 mg
Injectable; Injection; Somatropin recombinant 0.2 mg
Injectable; Injection; Somatropin recombinant 0.4 mg
Injectable; Injection; Somatropin recombinant 0.6 mg
Injectable; Injection; Somatropin recombinant 0.8 mg
Injectable; Injection; Somatropin recombinant 1 mg
Injectable; Injection; Somatropin recombinant 1.2 mg
Injectable; Injection; Somatropin recombinant 1.4 mg
Injectable; Injection; Somatropin recombinant 1.5 mg
Injectable; Injection; Somatropin recombinant 1.6 mg
Injectable; Injection; Somatropin recombinant 1.8 mg
Injectable; Injection; Somatropin recombinant 2 mg

References

  1. PubChem. "Somatropin". https://pubchem.ncbi.nlm.nih.gov/sub... (accessed September 17, 2018).
  2. DrugBank. "Somatotropin - DrugBank". http://www.drugbank.ca/drugs/DB00052 (accessed September 17, 2018).

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