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Egrifta WR
tesamorelin
Adult Dosing .
Dosage forms: INJ: 11.6 mg per vial
Special Note
- [formulation clarification]
- Info: tesamorelin products not interchangeable; do not substitute on a mg to mg basis
abdominal lipodystrophy, HIV-associated
- [1.28 mg SC qd]
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- hypothalamic-pituitary axis disruption
- hypopituitarism
- hypophysectomy
- malignancy, active
- pregnancy
- avoid: breastfeeding (pts w/ non-virological suppression throughout 3rd trimester)
- avoid: breastfeeding (pts w/ non-virological suppression postpartum)
- avoid: breastfeeding (pts w/ cracked nipple or bleeding nipple)
- avoid: breastfeeding (pts w/ mastitis)
- caution: malignancy hx
- caution: neoplasm hx, benign
- caution: diabetes mellitus
- caution: glucose intolerance
- caution: illness, acute critical
Drug Interactions .
Overview
tesamorelin
growth hormone releasing factor agonist
- 11-beta-hydroxysteroid dehydrogenase type 1 inhibitor
- affects growth hormone diagnostic test results
- hyperglycemic effects
- caution advised w/ drugs metabolized by CYP450 liver enzymes; tesamorelin stimulation of growth hormone production may modulate CYP450 metabolic function, alter levels of concomitant drugs, incr. risk of adverse effects or decr. efficacy
Avoid/Use Alternative
- desogestrel (contraceptive)
- dienogest (contraceptive)
- drospirenone (contraceptive)
- estradiol (contraceptive)
- ethinyl estradiol (contraceptive)
- ethynodiol (contraceptive)
- etonogestrel (contraceptive)
- levonorgestrel (contraceptive)
- levonorgestrel (post-coital contraceptive)
- macimorelin
- medroxyprogesterone (contraceptive)
- norelgestromin (contraceptive)
- norethindrone (contraceptive)
- norgestimate (contraceptive)
- norgestrel (contraceptive)
Monitor/Modify Tx
- acarbose
- alogliptin
- betamethasone
- bexagliflozin
- bromocriptine
- canagliflozin
- colesevelam
- cortisone
- cyclosporine
- dapagliflozin
- deflazacort
- dexamethasone
- dulaglutide
- empagliflozin
- ertugliflozin
- estradiol (hormone replacement)
- estrogens, conjugated (hormone replacement)
- estrogens, esterified (hormone replacement)
- ethinyl estradiol (hormone replacement)
- exenatide
- fludrocortisone
- fosphenytoin
- glimepiride
- glipizide
- glyburide
- insulin
- levonorgestrel (hormone replacement)
- linagliptin
- liraglutide
- medroxyprogesterone (hormone replacement)
- metformin
- methylprednisolone
- miglitol
- nateglinide
- norethindrone acetate (hormone replacement)
- norgestimate (hormone replacement)
- phenytoin
- pioglitazone
- pramlintide
- prednisolone
- prednisone
- repaglinide
- rosiglitazone
- saxagliptin
- semaglutide
- sitagliptin
- tirzepatide
- triamcinolone
Caution Advised
- levonorgestrel intrauterine device (contraceptive)
Adverse Reactions .
Serious Reactions
- hypersensitivity rxn
- malignancy risk
- diabetes mellitus
Common Reactions
- injection site rxn
- arthralgia
- myalgia
- peripheral edema
- extremity pain
- paresthesia
- diabetes mellitus
- hyperglycemia
- hypoesthesia
- rash
- vomiting
- pruritus
- dyspepsia
- pain
- musculoskeletal stiffness
- insulin-like growth factor-1 elevated
- carpal tunnel syndrome
Safety/Monitoring .
Monitoring Parameters
HbA1c, glucose at baseline, then periodically; insulin-like growth factor-1; ophthalmic exam at regular intervals if diabetes
Pregnancy/Lactation .
Pregnancy
Clinical Summary
contraindicated during pregnancy, use offers no benefit during pregnancy and may result in fetal harm; no human data available; possible risk of fetal hydrocephaly based on animal data at 2-4x recommended human dose
Lactation
Clinical Summary
weigh risk/benefit if virologically suppressed throughout 3rd trimester and postpartum, otherwise avoid breastfeeding; avoid breastfeeding if mastitis or nipples cracked or bleeding; give infant antiretroviral prophylaxis w/ zidovudine or nevirapine; risk of postnatal HIV transmission if non-virologically suppressed based on human data; risk of postnatal HIV transmission low if virologically suppressed based on limited human data; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: unknown; CYP450: none
Excretion: unknown; Half-life: 8min (2 mg/vial form), 11min (11.6 mg/vial form)
Subclass: Growth Hormones/Agonists
Mechanism of Action
stimulates growth hormone synthesis and release resulting in anabolic and lipolytic effects (growth hormone-releasing factor analog)
Formulary .
No Formulary Selected
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