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Egrifta

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Egrifta

Egrifta

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Neoplasms

EGRIFTA™ induces the release of endogenous growth hormone (GH), a known growth factor. Thus, patients with active malignancy should not be treated with EGRIFTA™ [see CONTRAINDICATIONS].

For patients with a history of non-malignant neoplasms, EGRIFTA™ therapy should be initiated after careful evaluation of the potential benefit of treatment. For patients with a history of treated and stable malignancies, EGRIFTA™ therapy should be initiated only after careful evaluation of the potential benefit of treatment relative to the risk of re-activation of the underlying malignancy.

In addition, the decision to start treatment with EGRIFTA™ should be considered carefully based on the increased background risk of malignancies in HIV-positive patients.

Elevated IGF-1

EGRIFTA™ stimulates GH production and increases serum IGF-1. Given that IGF-1 is a growth factor and the effect of prolonged elevations in IGF-1 levels on the development or progression of malignancies is unknown, IGF-1 levels should be monitored closely during EGRIFTA™ therapy. Careful consideration should be given to discontinuing EGRIFTA™ in patients with persistent elevations of IGF-1 levels (e.g., > 3 SDS), particularly if the efficacy response is not robust (e.g., based on visceral adipose tissue changes measured by waist circumference or CT scan).

During the clinical trials, patients were monitored every three months. Among patients who received EGRIFTA™ for 26 weeks, 47.4% had IGF-1 levels greater than 2 standard deviation scores (SDS), and 35.6% had SDS > 3, with this effect seen as early as 13 weeks of treatment. Among those patients who remained on EGRIFTA™ for a total of 52 weeks, at the end of treatment 33.7% had IGF-1 SDS > 2 and 22.6% had IGF-1 SDS > 3.

Fluid Retention

Fluid retention may occur during EGRIFTA™ therapy and is thought to be related to the induction of GH secretion. It manifests as increased tissue turgor and musculoskeletal discomfort resulting in a variety of adverse reactions (e.g. edema, arthralgia, carpal tunnel syndrome) which are either transient or resolve with discontinuation of treatment.

Glucose Intolerance

EGRIFTA™ treatment may result in glucose intolerance. During the Phase 3 clinical trials, the percentages of patients with elevated HbA1c ( ≥ 6.5%) from baseline to Week 26 were 4.5% and 1.3% in the EGRIFTA™ and placebo groups, respectively. An increased risk of developing diabetes with EGRIFTA™ (HbA1c level ≥ 6.5%) relative to placebo was observed [intent-to-treat hazard odds ratio of 3.3 (CI 1.4, 9.6)]. Therefore, glucose status should be carefully evaluated prior to initiating EGRIFTA™ treatment. In addition, all patients treated with EGRIFTA™ should be monitored periodically for changes in glucose metabolism to diagnose those who develop impaired glucose tolerance or diabetes. Diabetes is a known cardiovascular risk factor and patients who develop glucose intolerance have an elevated risk for developing diabetes. Caution should be exercised in treating HIV-positive patients with lipodystrophy with EGRIFTA™ if they develop glucose intolerance or diabetes, and careful consideration should be given to discontinuing EGRIFTA™ treatment in patients who do not show a clear efficacy response as judged by the degree of reduction in visceral adipose tissue by waist circumference or CT scan measurements.

Since EGRIFTA™ increases IGF-1, patients with diabetes who are receiving ongoing treatment with EGRIFTA™ should be monitored at regular intervals for potential development or worsening of retinopathy.

Hypersensitivity Reactions

Hypersensitivity reactions may occur in patients treated with EGRIFTA™ . Hypersensitivity reactions occurred in 3.6% of patients with HIV-associated lipodystrophy treated with EGRIFTA™ in the Phase 3 clinical trials. These reactions included pruritus, erythema, flushing, urticaria, and other rash. In cases of suspected hypersensitivity reactions, patients should be advised to seek prompt medical attention and treatment with EGRIFTA™ should be discontinued immediately.

Injection Site Reactions

EGRIFTA™ treatment may cause injection site reactions, including injection site erythema, pruritus, pain, irritation, and bruising. The incidence of injection site reactions was 24.5% in EGRIFTA™ -treated patients and 14.4% in placebo-treated patients during the first 26 weeks of treatment in the Phase 3 clinical trials. For patients who continued EGRIFTA™ for an additional 26 weeks, the incidence of injection site reactions was 6.1%. In order to reduce the incidence of injection site reactions, it is recommended to rotate the site of injection to different areas of the abdomen.

Acute Critical Illness

Increased mortality 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 has been reported after treatment with pharmacologic amounts of growth hormone. EGRIFTA™ has not been studied in patients with acute critical illness. Since EGRIFTA™ stimulates growth hormone production, careful consideration should be given to discontinuing EGRIFTA™ in critically ill patients.

Patient Counseling Information

See FDA-approved patient labeling (Patient Information and Patient Instructions for Use).

  • Fluid retention (5.3) - Advise patients that treatment with EGRIFTA™ may cause symptoms consistent with fluid retention, including edema, arthralgia, and carpal tunnel syndrome. These reactions are either transient or resolve with discontinuation of treatment.
  • Hypersensitivity Reactions (5.5) - Advise patients that hypersensitivity reactions (e.g., rash, urticaria) may occur during treatment with EGRIFTA™ . Advise patients to seek prompt medical attention and to immediately discontinue treatment with EGRIFTA™ .
  • Injection Site Reactions (5.6) - Advise patients of possible injection site reactions, including injection site erythema, pruritus, pain, irritation, and bruising. To reduce the incidence of injection site reactions, advise patients to rotate the site of injection.
  • Counsel patients that they should never share an EGRIFTA™ syringe with another person, even if the needle is changed. Sharing of syringes or needles between patients may pose a risk of transmission of infection.

Pregnancy

Advise women to discontinue EGRIFTA™ if pregnancy occurs, as the drug offers no known benefit to pregnant women and could result in fetal harm [see CONTRAINDICATIONS and Use In Specific Populations].

Nursing Mothers

Because of both the potential for HIV-1 infection transmission and serious adverse reactions in nursing infants, mothers receiving EGRIFTA™ should be instructed not to human milk-feed [see Use In Specific Populations].

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Life-time carcinogeniciry studies in rodents have not been conducted with tesamorelin acetate. No potential mutageniciry of tesamorelin acetate was revealed in a battery of tests including induction of gene mutations in bacteria (the Ames test), gene mutations in mammalian cells grown in vitro (hamster CHOK1 cells), and chromosomal damage in intact animals (bone marrow cells in mice). There was no effect on fertility in male or female rats following administration of tesamorelin acetate at doses up to 0.6 mg/kg (approximately equal to clinical exposure) for 28 days in males or 14 days in females. In the 26-week toxiciry study in rats, females given approximately 16 and 25 times the clinical dose were more likely to be in diestrus.

Use In Specific Populations

Pregnancy

Pregnancy Category X [see CONTRAINDICATIONS].

EGRIFTA™ is contraindicated in pregnant women. During pregnancy, visceral adipose tissue increases due to normal metabolic and hormonal changes. Modifying this physiologic change of pregnancy with EGRIFTA™ offers no known benefit and could result in fetal harm. Tesamorelin acetate administration to rats during organogenesis and lactation resulted in hydrocephaly in offspring at a dose of approximately two and four times the clinical dose, respectively, based on measured drug exposure (AUC). If pregnancy occurs, discontinue EGRIFTA™ therapy. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

Tesamorelin acetate administration to rats during organogenesis and lactation produced hydrocephaly in offspring at a dose of approximately two and four times the clinical dose, respectively, based on measured drug exposure (AUC). Actual animal dose was 1.2 mg/kg. During organogenesis, lower doses approximately 0.1 to 1 times the clinical dose caused delayed skull ossification in rats. Actual animal doses were 0.1 to 0.6 mg/kg. No adverse developmental effects occurred in rabbits using doses up to approximately 500 times the clinical dose.

Nursing Mothers

The Centers for Disease Control and Prevention recommend that HTV-infected mothers in the United States not human milk-feed their infants to avoid risking postnatal transmission of HTV-1 infection. Because of both the potential for HTV-1 infection transmission and serious adverse reactions in nursing infants, mothers receiving EGRIFTA™ should be instructed not to human milk-feed.

It is not known whether EGRIFTA™ is excreted in human milk. Tesamorelin acetate administration to rats during organogenesis and lactation resulted in hydrocephaly in offspring at a dose of approximately two and four times the clinical dose, respectively, based on measured drug exposure (AUC). Actual animal dose was 1.2 mg/kg.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established. EGRIFTA™ should not be used in children with open epiphyses, among whom excess GH and IGF-1 may result in linear growth acceleration and excessive growth.

Geriatric Use

There is no information on the use of EGRIFTA™ in patients greater than 65 years of age with HIV and lipodystrophy.

Renal and Hepatic Impairment

Safety, efficacy, and pharmacokinetics of EGRIFTA™ in patients with renal or hepatic impairment have not been established.

Last reviewed on RxList: 12/12/2011
This monograph has been modified to include the generic and brand name in many instances.

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