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Egrifta SV

Last reviewed on RxList: 5/15/2020
Egrifta SV Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Egrifta SV?

Egrifta SV (tesamorelin kit) is a growth hormone releasing factor (GHRF) analog used to reduce excess abdominal fat in HIV-infected adult patients with lipodystrophy.

What Are Side Effects of Egrifta SV?

Side effects of Egrifta SV include:

  • joint pain,
  • injection site reactions (redness, itching),
  • pain in extremities,
  • swelling of extremities, and
  • muscle pain

Dosage for Egrifta SV

The dose of Egrifta SV is 1.4 mg (0.35 mL of the reconstituted solution) injected subcutaneously once daily.

Egrifta SV In Children

The safety and effectiveness of Egrifta SV in pediatric patients have not been established.

In pediatric patients with open epiphyses, treatment with Egrifta SV may result in linear growth acceleration and excessive growth. Egrifta SV is not indicated for use in pediatric patients with open or closed epiphyses.

What Drugs, Substances, or Supplements Interact with Egrifta SV?

Egrifta SV may interact with other medicines such as:

  • cytochrome P450-metabolized drugs (such as corticosteroids, sex steroids, anticonvulsants, and cyclosporine) and
  • glucocorticoid replacement for previously diagnosed hypoadrenalism

Tell your doctor all medications and supplements you use.

Egrifta SV During Pregnancy and Breastfeeding

Egrifta SV is not recommended for use during pregnancy. Modifying visceral adipose tissue offers no benefit in a pregnant woman and could result in fetal harm. It is unknown if Egrifta SV passes into breast milk. The Centers for Disease Control and Prevention recommend that HIV-infected mothers in the United States not breastfeed their infants to avoid risking postnatal transmission of HIV-1 infection.

Additional Information

Our Egrifta SV (tesamorelin kit) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

What is HIV? See Answer
Egrifta SV Professional Information

SIDE EFFECTS

The following important adverse reactions are also described elsewhere in the labeling:

  • Increased risk of neoplasms [see WARNINGS AND PRECAUTIONS]
  • Elevated IGF-1 levels [see WARNINGS AND PRECAUTIONS]
  • Fluid retention [see WARNINGS AND PRECAUTIONS]
  • Glucose intolerance or diabetes mellitus [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity reactions [see WARNINGS AND PRECAUTIONS]
  • Injection site reactions [see WARNINGS AND PRECAUTIONS]

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of EGRIFTA SV (2 mg/vial formulation) has been established based on clinical trials conducted with EGRIFTA (1 mg/vial formulation). Adverse reactions for the 1.4 mg dose (2 mg/vial formulation) of EGRIFTA SV are expected to be similar to those observed with the 2 mg dose (1 mg/vial formulation) of EGRIFTA [see CLINICAL PHARMACOLOGY].

Seven hundred and forty (740) HIV-infected patients with lipodystrophy and excess abdominal fat were treated with EGRIFTA in clinical trials; of these, 543 received EGRIFTA during the initial 26-week placebo-controlled phase.

The most commonly reported adverse reactions were hypersensitivity reactions (e.g., rash, urticaria), edema-related reactions (e.g., arthralgia, extremity pain, peripheral edema, and carpal tunnel syndrome), hyperglycemia, and injection site reactions (injection site erythema, pruritus, pain, urticaria, irritation, swelling, and hemorrhage).

Adverse reactions that occurred more frequently with EGRIFTA relative to placebo and had an incidence ≥1% during the first 26 weeks across all studies are presented in Table 1.

Table 1: Adverse Reactions Reported in ≥ 1% and More Frequent in EGRIFTA -treated than Placebo Patients during the 26-Week Phase (Combined Studies )

Preferred TermPlacebo
(N=263)
EGRIFTA
(N=543)
Injection site reaction*617
Arthralgia1113
Pain in extremity56
Myalgia26
Edema peripheral26
Paresthesia25
Hypoesthesia24
Rash24
Dyspepsia12
Musculoskeletal pain12
Pain12
Pruritus12
Vomiting03
Musculoskeletal stiffness02
Blood creatine phosphokinase increased01
Carpal tunnel syndrome01
Joint swelling01
Muscle strain01
Night sweats01
Palpitations01
* Injection site reaction includes: Injection site erythema, Injection site pruritus, Injection site rash, Injection site urticaria, Injection site pain, Injection site swelling, Injection site irritation, Injection site hemorrhage.

In the EGRIFTA clinical trials, mean baseline HbA1c was 5.3% among patients in both the EGRIFTA and placebo groups. Patients receiving EGRIFTA had an increased risk of developing diabetes (HbA1c level ≥ 6.5%) compared with placebo (5% vs. 1%), with a hazard ratio of 3.3 (CI 1.4, 9.6).

Immunogenicity

As with all therapeutic proteins and peptides, there is a potential for development of anti-EGRIFTA antibodies. The observed incidence of antibody positivity in an assay is highly dependent on several factors, including assay sensitivity and specificity, methodology, sample handling, timing of sample collection, concomitant medication and underlying disease. For these reasons, comparison of the incidence of antibodies to EGRIFTA with the incidence of antibodies to other products may be misleading.

In the clinical trials with the EGRIFTA 1 mg/vial formulation, anti-tesamorelin IgG antibodies were detected in 50% of patients who received EGRIFTA for 26 weeks and 47% of patients who received EGRIFTA for 52 weeks. In the subset of patients with hypersensitivity reactions, antitesamorelin IgG antibodies were detected in 85%. Cross-reactivity to endogenous growth hormonereleasing hormone (GHRH) was observed in approximately 60% of patients who developed antitesamorelin antibodies. Patients with and without anti-tesamorelin IgG antibodies had similar mean reductions in visceral adipose tissue (VAT) and IGF-1 response. In a group of patients who had antibodies to tesamorelin after 26 weeks of treatment (56%) and were re-assessed 6 months later, after stopping EGRIFTA treatment, 18% were still antibody positive.

Neutralizing antibodies to tesamorelin and human GHRH (hGHRH) were detected in vitro at Week 52 in 10% and 5% of EGRIFTA-treated patients, respectively. Changes in VAT and IGF-1 levels in patients with or without in vitro neutralizing antibodies were comparable.

Read the entire FDA prescribing information for Egrifta SV (Tesamorelin for Injection)

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© Egrifta SV Patient Information is supplied by Cerner Multum, Inc. and Egrifta SV Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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