Egrifta SV (tesamorelin)

Egrifta SV may cause serious side effects, including:

• increased risk of new cancer in HIV positive patients or your cancer coming back (reactivation). Stop using Egrifta SV if any cancer symptoms come back.
• increased levels of your insulin-like growth factor-1 (IGF-1). Your healthcare provider will do blood tests to check your IGF-1 levels while you are taking Egrifta SV.
• swelling (fluid retention). Egrifta SV can cause swelling in some parts of your body. Call your healthcare provider if you have swelling, an increase in joint pain or pain or numbness in your hands or wrist (carpal tunnel syndrome). Joint pain and swelling of your arms, hands, legs and feet are common side effects of Egrifta SV, but may sometimes be serious.
• increase in blood sugar (glucose) or diabetes. Your healthcare provider will check your blood sugar before you start taking Egrifta SV and during your treatment with Egrifta SV.
• serious allergic reaction. Some people using Egrifta SV may have an allergic reaction. Stop using Egrifta SV and get emergency medical help right away if you have any of the following symptoms :
  • a rash over your body
  • shortness of breath or trouble breathing
  • hives
  • fast heartbeat
  • itching
  • swelling of your face or throat
  • feeling of faintness or fainting
  • reddening or flushing of the skin
• injection site reactions. Injection site reactions are a common side effect of Egrifta SV, but may sometimes be serious. Change (rotate) your injection site to help lower your risk for injection site reactions. Call your healthcare provider for medical advice if you have any of the following symptoms around the area of the injection site:
  • redness
  • irritation
  • swelling
  • itching
  • bruising or bleeding
  • pain
  • rash
• increased risk of death in people who have critical illnesses because of heart or stomach surgery, trauma or serious breathing (respiratory) problems has happened when taking certain amounts of growth hormone.

The most common side effects of Egrifta SV include:

• pain in legs and arms
• muscle pain

These are not all the possible side effects of Egrifta SV. For more information, ask your healthcare provider or pharmacist.

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

• The dosage and administration recommendations in this prescribing information only apply to Egrifta SV (tesamorelin for injection) 2 mg per vial formulation. For dosage and administration recommendations for tesamorelin for injection 1 mg per vial formulation, see the Egrifta prescribing information. These two formulations and strengths have differences in the dosage, the number of vials required to prepare a dose, reconstitution instructions, and storage requirements.
• The dose of Egrifta SV is 1.4 mg, 0.35 mL of the reconstituted solution, injected subcutaneously once daily.
• Inject Egrifta SV into the abdomen. Rotate injection sites to different areas of the abdomen. Do not inject into scar tissue, bruises or the navel.

Cytochrome P450-Metabolized Drugs

• Co-administration of tesamorelin with simvastatin, a CYP3A substrate had no significant impact on the pharmacokinetics profiles of simvastatin in healthy subjects.
• Egrifta SV stimulates GH production. Published data indicate that GH may modulate cytochrome P450 (CYP450) mediated antipyrine clearance.
• These data suggest that GH may alter the clearance of compounds known to be metabolized by CYP450 liver enzymes (e.g., corticosteroids, sex steroids, anticonvulsants, and cyclosporine).
• Monitor patients for potential interactions when administering Egrifta SV in combination with other drugs known to be metabolized by CYP450 liver enzymes.

Glucocorticoids

• GH inhibits 11β-hydroxysteroid dehydrogenase type 1 (11βHSD-1), a microsomal enzyme required for conversion of cortisone to its active metabolite, cortisol, in hepatic and adipose tissue.
• Egrifta SV stimulates GH production; therefore, patients receiving glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in maintenance or stress doses following initiation of Egrifta SV.
• Patients treated with cortisone acetate and prednisone may be affected more than others because conversion of these drugs to their biologically active metabolites is dependent on the activity of 11βHSD-1.

• Advise women to discontinue Egrifta SV if pregnancy occurs, as the drug offers no known benefit to pregnant women and could result in fetal harm.
• Because of both the potential for HIV-1 infection transmission and serious adverse reactions in nursing infants, mothers receiving Egrifta SV should be instructed not to breastfeed.