Tesamorelin

Tesamorelin is a prescription medication used for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy.

• Tesamorelin is available under the following different brand names: Egrifta

Common side effects of Tesamorelin include:

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

Serious side effects of Tesamorelin include:

• hives
• difficult breathing
• swelling of the face, lips, tongue, or throat
• swelling in the 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 the hands or fingers
• pounding heartbeats or fluttering in the chest
• high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss)

Rare side effects of Tesamorelin include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

• Injection, lyophilized powder for reconstitution
• 1 mg/vial (kit containing 2 vials, diluent, syringe, and needles)

HIV-associated lipodystrophy

Adult dosage

• 2 mg SC once daily

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Tesamorelin has severe interactions with no other drugs
• Tesamorelin has serious interactions with the following drugs:
  • cortisone
  • prednisone
  • ulipristal
• Tesamorelin has moderate interactions with the following drugs:
  • bazedoxifene/conjugated estrogens
  • carbamazepine
  • conjugated estrogens
  • conjugated estrogens, vaginal
  • diazoxide
  • estradiol combos
  • exenatide injectable solution
  • exenatide injectable suspension
  • irinotecan liposomal
  • levonorgestrel intrauterine
  • levonorgestrel oral
  • medroxyprogesterone
  • norethindrone
  • phenytoin
  • theophylline
• Tesamorelin has minor interactions with no other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity to tesamorelin or mannitol
• Disruption of the hypothalamic-pituitary axis caused by hypophysectomy, hypopituitarism, pituitary tumor/surgery, head irradiation, or head trauma
• Active malignancy
• Pregnancy

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Tesamorelin?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Tesamorelin?”

Cautions

• Caution with a history of nonmalignant neoplasms; preexisting malignancy should be inactive, and treatment complete before initiating therapy
• If hypersensitivity is suspected, discontinue, and provide immediate medical attention.
• Consider discontinuing persistent elevations of IGF-I levels (e.g., above 3 SDS), particularly if the efficacy response is not robust
• Fluid retention may occur, including edema, arthralgia, and carpal tunnel syndrome
• Increased mortality with acute critical illness due to complications following open heart surgery, abdominal surgery, multiple accidental trauma, or acute respiratory failure following treatment with pharmacologic amounts of growth hormone
• May modulate CYP450-mediated antipyrine clearance
• Not for use in children when epiphyses open because may cause excessive growth
• Inhibits 11-beta-hydroxysteroid dehydrogenase type-1, a microsomal enzyme required for the conversion of cortisone and prednisone to their active metabolites
• Injections site reactions including irritation, erythema, pain, and bruising may occur; rotate the site of injection to different areas of the abdomen to reduce the incidence of injection site reactions
• May increase the risk of development of diabetes due to glucose intolerance; evaluate glucose status before and during therapy
• Not indicated for weight loss management

Pregnancy and Lactation

• Contraindicated
  • During pregnancy, visceral adipose tissue increases due to normal metabolic and hormonal changes; modifying this physiologic change offers no known benefit and could result in fetal harm
  • Administration to rats during organogenesis and lactation resulted in hydrocephaly in offspring at 2 to 4 times the clinical dose
• Lactation
  • Centers for Disease Control and Prevention (CDC) recommend that HIV-infected mothers in the United States, not human milk-feed their infants to avoid risking postnatal transmission of HIV-1 infection
  • Because of both the potential for HIV-1 infection transmission and serious adverse reactions in nursing infants, breastfeeding women should be instructed not to human milk-feed