Egrifta

What Is Egrifta?

Egrifta (tesamorelin) for Injection is made with growth hormone-releasing factor (GRF) and is used to reduce excess fat around the stomach that is caused by taking certain HIV medications. This condition is called lipodystrophy. Egrifta is not a weight-loss medication and should not be used to treat obesity.

What Are Side Effects of Egrifta?

Common side effects of Egrifta include:

• injection site reactions (redness, itching, pain, irritation, swelling, bleeding, or bruising)
• muscle aches or spasm
• depression
• sleep problems (insomnia)
• night sweats
• rash or itching
• nausea
• vomiting, or
• upset stomach

Dosage for Egrifta

The recommended dose of Egrifta is 2 mg injected subcutaneously (under the skin) into the abdomen once a day.

What Drugs, Substances, or Supplements Interact with Egrifta?

Egrifta may interact with cyclosporine, testosterone or hormone replacement therapy, seizure medications, or steroids. Tell your doctor all medications and supplements you use.

Egrifta During Pregnancy or Breastfeeding

Egrifta must not be used during pregnancy. It may harm a fetus. If you become pregnant or think you may be pregnant, tell your doctor. It is unknown if this drug passes into breast milk. Because breast milk can transmit HIV, do not breastfeed.

Additional Information

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

 

Egrifta Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using tesamorelin and call your doctor at once if you have a serious side effect such as:

• swelling in your hands, ankles, or feet;
• pain or stiffness in your muscles or joints;
• pain in your arms or legs;
• wrist pain or numbness;
• numbness or tingling in your hands or fingers;
• pounding heartbeats or fluttering in your chest;
• high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss);

Less serious side effects may include:

• depressed mood, sleep problems (insomnia);
• night sweats;
• mild rash or itching;
• muscle spasm;
• nausea, vomiting, upset stomach;
• pain, redness, itching, swelling, bruising, bleeding, or other irritation where the injection was given;

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.

Read the entire detailed patient monograph for Egrifta (Tesamorelin Injection)

 

Egrifta 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 Term	Placebo (N=263)	EGRIFTA (N=543)
Injection site reaction*	6	17
Arthralgia	11	13
Pain in extremity	5	6
Myalgia	2	6
Edema peripheral	2	6
Paresthesia	2	5
Hypoesthesia	2	4
Rash	2	4
Dyspepsia	1	2
Musculoskeletal pain	1	2
Pain	1	2
Pruritus	1	2
Vomiting	0	3
Musculoskeletal stiffness	0	2
Blood creatine phosphokinase increased	0	1
Carpal tunnel syndrome	0	1
Joint swelling	0	1
Muscle strain	0	1
Night sweats	0	1
Palpitations	0	1
*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 HbA_1c was 5.3% among patients in both the EGRIFTA and placebo groups. Patients receiving EGRIFTA had an increased risk of developing diabetes (HbA_1c 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, anti-tesamorelin IgG antibodies were detected in 85%. Cross-reactivity to endogenous growth hormone-releasing hormone (GHRH) was observed in approximately 60% of patients who developed anti-tesamorelin 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 (Tesamorelin Injection)