Dosing & Uses
Dosage Forms & Strengths
injection, lyophilized powder for reconstitution
- 1mg/vial (kit containing 2 vials, diluent, syringe, and needles)
HIV-Associated Lipodystrophy
Indicated for reduction of excess abdominal fat in HIB-infected patients with lipodystrophy
2 mg SC once daily
Dosing Considerations
Limitations of use
- Long-term cardiovascular benefit and safety not studied
- Not indicated for weight loss management (weight neutral effect)
- There are no data to support improved compliance with antiretroviral therapies in HIV-positive patients taking tesamorelin
Safety and efficacy not established
Should not be used in children with open epiphyses, among whom excess GH and IGF-I may result in linear growth acceleration and excessive growth
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (4)
- cortisone
tesamorelin will decrease the level or effect of cortisone by altering metabolism. Avoid or Use Alternate Drug. Patients receiving glucocorticoid replacement therapy with cortisone may require increased doses; monitor for reduce effects of cortisone therapy
- macimorelin
tesamorelin, macimorelin. unspecified interaction mechanism. Avoid or Use Alternate Drug. Drugs that may blunt the growth hormone (GH) response to macrimorelin may impact the accuracy of the diagnostic test. Discontinue GH products at least 1 week before administering macimorelin. .
- prednisone
tesamorelin will decrease the level or effect of prednisone by altering metabolism. Avoid or Use Alternate Drug. Patients receiving glucocorticoid replacement therapy with prednisone may require increased doses; monitor patients for reduced prednisone effect
- ulipristal
tesamorelin will decrease the level or effect of ulipristal by altering metabolism. Avoid or Use Alternate Drug.
Monitor Closely (15)
- bazedoxifene/conjugated estrogens
tesamorelin will decrease the level or effect of bazedoxifene/conjugated estrogens by altering metabolism. Use Caution/Monitor. May decrease efficacy; monitor
- carbamazepine
tesamorelin will decrease the level or effect of carbamazepine by altering metabolism. Modify Therapy/Monitor Closely. Monitor levels
- conjugated estrogens
tesamorelin will decrease the level or effect of conjugated estrogens by altering metabolism. Use Caution/Monitor. May decrease efficacy; monitor
- conjugated estrogens, vaginal
tesamorelin will decrease the level or effect of conjugated estrogens, vaginal by altering metabolism. Use Caution/Monitor. May decrease efficacy; monitor
- diazoxide
tesamorelin will decrease the level or effect of diazoxide by altering metabolism. Modify Therapy/Monitor Closely. Monitor glucose levels
- estradiol combos
tesamorelin will decrease the level or effect of estradiol combos by altering metabolism. Use Caution/Monitor. Use alternative contraception
- exenatide injectable solution
tesamorelin will decrease the level or effect of exenatide injectable solution by altering metabolism. Modify Therapy/Monitor Closely. Monitor glucose levels
- exenatide injectable suspension
tesamorelin will decrease the level or effect of exenatide injectable suspension by altering metabolism. Modify Therapy/Monitor Closely. Monitor glucose levels
- irinotecan liposomal
tesamorelin will decrease the level or effect of irinotecan liposomal by altering metabolism. Use Caution/Monitor. Avoid combo. Consider discontinuation of tesamelin at least 2 weeks before initiating irinotecan therapy.
- levonorgestrel intrauterine
tesamorelin will decrease the level or effect of levonorgestrel intrauterine by altering metabolism. Use Caution/Monitor. Use alternative contraception
- levonorgestrel oral
tesamorelin will decrease the level or effect of levonorgestrel oral by altering metabolism. Use Caution/Monitor. Use alternative contraception
- medroxyprogesterone
tesamorelin will decrease the level or effect of medroxyprogesterone by altering metabolism. Use Caution/Monitor. Use alternative contraception
- norethindrone
tesamorelin will decrease the level or effect of norethindrone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Use alternative contraception
- phenytoin
tesamorelin will decrease the level or effect of phenytoin by altering metabolism. Modify Therapy/Monitor Closely. Monitor levels
- theophylline
theophylline will decrease the level or effect of tesamorelin by altering metabolism. Modify Therapy/Monitor Closely. Monitor theophylline levels
Minor (0)
Adverse Effects
>10%
Arthralgia (13.3%)
1-10%
Injection site reactions (up to 8.5%)
Extremity pain (6.1%)
Myalgia (5.5%)
Paresthesia (4.8%)
Nausea (4.4%)
Hypoesthesia (4.2%)
Rash (3.7%)
Vomiting (2.6%)
Pruritus (2.4%)
Depression (2%)
Dyspepsia (1.7%)
Musculoskeletal pain and stiffness (1.7-1.8%)
Increased CPK (1.5%)
Carpal tunnel syndrome (1.5%)
Joint stiffness/swelling (1.1-1.5%)
Hypertension (1.3%)
Muscle spasms (1.1%)
<1%
Anemia
Abdominal abscess
Cerebellar syndrome
Mental status changes
Sepsis
Trigeminal neuralgia
Viral bronchitis
Upper respiratory tract infection
Warnings
Contraindications
Hypersensitivity to tesamorelin or mannitol
Disruption of hypothalamic-pituitary (HP) axis caused by hypophysectomy, hypopituitarism, pituitary tumor/surgery, head irradiation, or head trauma
Active malignancy
Pregnancy
Cautions
Caution with history of nonmalignant neoplasms; preexisting malignancy should be inactive and treatment complete prior to initiating therapy
If hypersensitivity suspected, discontinue and provide immediate medical attention
Consider discontinuing with persistent elevations of IGF-I levels (eg, >3 SDS), particularly if efficacy response is not robust
Fluid retention may occur and may include 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 conversion of cortisone and prednisone to their active metabolites
Injections site reactions including irritation, erythema, pain, and bruising may occur; rotate site of injection to different areas of abdomen to reduce incidence of injection site reactions
May increase risk of development of diabetes due to glucose intolerance; evaluate glucose status prior to and during therapy
Not indicated for weight loss management
Pregnancy & Lactation
Pregnancy
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 2-4 times clinical dose
Lactation
Centers for Disease Control and Prevention 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
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Growth hormone releasing factor (GRF) analog; stimulates growth hormone production and increases serum IGF-I; elicits anabolic and lipolytic actions
Pharmacokinetics
Half-life: 38 minutes
Absorption: <4%
Peak plasma time: 9 min
Peak plasma concentration: 2822.3 pg/mL
Vd: 10.5 L/kg (HIV infected patients); 9.4 L/kg (healthy adults)
Bioavailability: <4% (healthy adults)
Administration
SC Preparation
Lyophilized powder for reconstitution
- Reconstitute 2 vials of 1-mg lyophilized powder with supplied diluent
Reconstitute first 1-mg vial
- Reconstitute first 1-mg vial with 2.2 mL of diluent
- Mix by rolling the vial gently in your hands for 30 seconds
- Do not shake
Reconstitute second 1-mg vial
- Reconstitute the second 1-mg vial with the entire solution from the first reconstituted vial
- Mix by rolling the vial gently in your hands for 30 seconds
- Do not shake
- Visually inspect for particulate matter and discoloration; solution should appear clear, colorless, and without particulate matter
SC Administration
Inject SC in abdomen
Rotate injection sites to different abdominal areas of the abdomen
Do not inject into scar tissue, bruises, or the navel
Storage
Unopened vial and diluent
- Unopened vials: Store refrigerated between 2-8°C (36-46°F); protect from light and keep in original box until time of use; do not freeze
- Diluent, syringes, and needles: Store at controlled room temperature of 20-25°C (68-77°F)
Reconstituted solution
- Do not freeze or refrigerate
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Egrifta SV subcutaneous - | 2 mg vial |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
tesamorelin subcutaneous
TESAMORELIN - INJECTION
(TES-a-moe-REL-in)
COMMON BRAND NAME(S): Egrifta, Egrifta SV
USES: This medication is used to reduce excess fat in the stomach area (abdomen) in people with HIV infection who have changes in the way their body fat is distributed. Some HIV drugs may cause this side effect (increased fat in the upper back and stomach areas, decreased fat in the arms and legs). Tesamorelin works by causing your body to make more growth hormone.This medication should not be used for weight loss.
HOW TO USE: Read the Patient Information Leaflet and Patient Instructions for Use provided by your pharmacist before starting this medication and each time you get a refill. A health care professional will teach you how to properly use this medication. Learn all preparation and usage instructions in the product package or from your health care professional. If any of the information is unclear, consult your doctor or pharmacist.Wash your hands with soap and water before using this medication. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.Inject this medication under the skin on your stomach (abdomen) as directed by your doctor, usually once daily. To help you remember, use it at the same time each day.Pick an injection site that is below your belly button to the left or right. Avoid any area with scar tissue, bruises, reddening, or irritation. Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin.Learn how to store and discard needles and medical supplies safely. Consult your pharmacist for more details.
SIDE EFFECTS: Redness, itching, pain, irritation, or bruising at the injection site may occur. Muscle aches may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor 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 you have any serious side effects, including: muscle/joint pain or stiffness, numbness/tingling/swelling in your arms or legs.This medication may rarely make your blood sugar rise, which can cause or worsen diabetes. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. If you already have diabetes, check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet.This medication may rarely increase the risk of getting a new cancer or of a previous cancer coming back. Talk with your doctor for details.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 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: cancer, diabetes, tumors, hypothalamus or pituitary gland problems (such as due to head injury, pituitary tumor/surgery).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).This medication must not be used during pregnancy. It may harm an unborn baby. If you become pregnant or think you may be pregnant, tell your doctor right away.It is unknown if this medication passes into breast milk. Because breast milk may transmit HIV, consult your doctor before breastfeeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others.Lab and/or medical tests (such as blood sugar, IGF-1 levels) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.
MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.
STORAGE: Different brands of this medication have different storage needs. Check the product package for instructions on how to store your brand, or ask your pharmacist. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised October 2023. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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