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Egrifta

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Egrifta

Egrifta Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

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. It is not a weight-loss medication and should not be used to treat obesity. Common side effects include redness, itching, pain, irritation, or bruising at the injection site. Muscle aches may also occur.

The recommended dose of Egrifta is 2 mg injected subcutaneously (under the skin) into the abdomen once a day. Egrifta may interact with cyclosporine, testosterone or hormone replacement therapy, seizure medications, or steroids. Tell your doctor all medications and supplements you use. 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.

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.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Egrifta in Detail - Patient Information: Side Effects

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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Egrifta Overview - Patient Information: Side Effects

SIDE EFFECTS: Redness, itching, pain, irritation, or bruising at the injection site may occur. Muscle aches may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: muscle/joint pain or stiffness, numbness/tingling/swelling in your arms or legs.

This medication may infrequently make your blood sugar level rise, which can cause or worsen diabetes. Tell your doctor immediately if you develop symptoms of high blood sugar, such as increased thirst and urination. If you already have diabetes, be sure to check your blood sugars regularly. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Egrifta (Tesamorelin Injection)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Egrifta FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The most commonly reported adverse reactions are hypersensitivity (e.g., rash, urticaria) reactions due to the effect of GH (e.g., arthralgia, extremity pain, peripheral edema, hyperglycemia, carpal tunnel syndrome), injection site reactions (injection site erythema, pruritis, pain, urticaria, irritation, swelling, hemorrhage).

During the first 26 weeks of treatment (main phase), discontinuations as a result of adverse reactions occurred in 9.6% of patients receiving EGRIFTA™ and 6.8% of patients receiving placebo. Apart from patients with hypersensitivity reactions identified during the studies and who were discontinued per protocol (2.2%), the most common reasons for discontinuation of EGRIFTA™ treatment were adverse reactions due to the effect of GH (4.2%) and local injection site reactions (4.6%).

During the following 26 weeks of treatment (extension phase), discontinuations as a result of adverse events occurred in 2.4% of patients in the T-T group (patients treated with tesamorelin for Week 0-26 and with tesamorelin for Week 26-52) and 5.2% of patients in the T-P group (patients treated with tesamorelin for Week 0-26 and with placebo for Week 26-52).

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.

Seven hundred and forty HTV-infected patients with lipodystrophy and excess abdominal fat were exposed to EGRIFTA™ in the Phase 3 clinical trials; of these 543 received EGRIFTA™ during the initial 26-week placebo-controlled phase [see Clinical Studies].

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 Main Phase (Combined Studies)

  Incidence of patients (%) with adverse drug reactions
System Organ Class
Preferred Term
EGRIFTA™
(N=543)
Placebo
(N=263)
Musculoskeletal and connective tissue disorders
  Arthralgia 13.3 11.0
  Pain in extremity 6.1 4.6
  Myalgia 5.5 1.9
  Musculoskeletal pain 1.8 0.8
  Musculoskeletal stiffness 1.7 0.4
  Joint stiffness 1.5 0.8
  Muscle spasms 1.1 0.8
  Joint swelling 1.1 0.0
General disorders and administration site conditions
  Injection site erythema 8.5 2.7
  Injection site pruritus 7.6 0.8
  Edema peripheral 6.1 2.3
  Injection site pain 4.1 3.0
  Injection site irritation 2.9 1.1
  Pain 1.7 1.1
  Injection site hemorrhage 1.7 0.4
  Injection site urticaria 1.7 0.4
  Injection site swelling 1.5 0.4
  Injection site reaction 1.3 0.8
  Chest pain 1.1 0.8
  Injection site rash 1.1 0.0
Nervous system disorders
  Paresthesia 4.8 2.3
  Hypoesthesia 4.2 1.5
  Carpal tunnel syndrome 1.5 0.0
Gastrointestinal disorders
  Nausea 4.4 3.8
  Vomiting 2.6 0.0
  Dyspepsia 1.7 0.8
  Abdominal pain upper 1.1 0.8
Cardiac disorders
  Palpitations 1.1 0.4
Psychiatric disorders
  Depression 2.0 1.5
Skin and subcutaneous tissue disorders
  Rash 3.7 1.5
  Pruritus 2.4 1.1
  Night sweats 1.1 0.4
Vascular disorders
  Hypertension 1.3 0.8
Injury, poisoning and procedural complications
  Muscle strain 1.1 0.0
Investigations
  Blood creatine phosphokinase increased 1.5 0.4

Mean levels of fasting blood glucose and fasting insulin were not significantly different between EGRIFTA™ -treated and placebo-treated patients after 26 weeks of treatment.

In the EGRIFTA™ Phase 3 clinical trials, mean baseline (Week 0) HbA1c was 5.26% among patients in the EGRIFTA™ group and 5.28% among those in the placebo group. At Week 26, mean HbAic was higher among patients treated with EGRIFTA™ compared with placebo (5.39% vs. 5.28% for the EGRIFTA™ and placebo groups, respectively, mean treatment difference of 0.12%, p=0.0004). Patients receiving EGRIFTA™ had an increased risk of developing diabetes (HbA1c level ≥ 6.5%) compared with placebo (4.5% vs. 1.3%), with a hazard ratio of 3.3 (CI 1.4, 9.6).

Adverse reactions observed during Week 26 to 52 of the Phase 3 clinical trials which had an incidence of ≥ 1% and were seen more frequently with EGRIFTA™ relative to placebo are presented in Table 2:

Table 2. Adverse Reactions Reported in ≥ 1% and More Frequent in EGRIFTA™ -treated than Placebo Patients during the 26-Week Extension Phase of the Combined Studies (Week 26 to Week 52 of the studies)

System Organ Class
Preferred Term
Incidence of patients (%) with adverse drug reactions
T-T1 (Week 26-52)
(N=246)
T-P2 (Week 26-52)
(N=135)
Musculoskeletal and connective tissue disorders
  Pain in extremity 3.3 0.7
  Myalgia 1.2 0.0
General disorders and administration site conditions
  Injection site pruritus 2.0 0.0
  Edema peripheral 2.0 0.0
  Injection site erythema 1.2 0.0
Nervous system disorders
  Paresthesia 1.6 1.5
  Hypoesthesia 1.6 0.7
  Neuropathy peripheral 1.6 1.5
Gastrointestinal disorders
  Vomiting 2.0 0.7
Psychiatric disorders
  Depression 1.6 0.7
  Insomnia 1.2 0.0
Skin and subcutaneous tissue disorders
  Pruritus 1.2 0.7
  Urticaria 1.2 0.0
  Night sweats 1.2 0.0
Vascular disorders
  Hypertension 1.6 1.5
  Hot flush 1.2 0.7
1 T-T = tesamorelin for Week 0-26 and tesamorelin for Week 26-52
2 T-P = tesamorelin for Week 0-26 and placebo for Week 26-52

For patients who continued from Week 26-52, mean levels of fasting blood glucose, fasting insulin, and HbA1c were not different between the T-T and T-P groups.

Immunogenicity

As with all therapeutic proteins and peptides, there is a potential for in vivo development of anti-EGRIFTA™ antibodies. In the combined Phase 3 clinical trials anti-tesamorelin IgG antibodies were detected in 49.5% of patients treated with EGRIFTA™ for 26 weeks and 47.4% of patients who received EGRIFTA™ for 52 weeks. In the subset of patients with hypersensitivity reactions, anti-tesamorelin IgG antibodies were detected in 85.2%. 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 suggesting that the presence of antibodies did not alter the efficacy of EGRIFTA™ . 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 hGHRH were detected in vitro at Week 52 in 10% and 5% of EGRIFTA™ -treated patients, respectively. They did not appear to have an impact on efficacy, as evidenced by comparable changes in VAT and IGF-1 level in patients with or without in vitro neutralizing 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.

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

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Egrifta - User Reviews

Egrifta User Reviews

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Here is a collection of user reviews for the medication Egrifta sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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