Lutropin Alfa

Lutropin alfa is used for follicle stimulation.

Lutropin alfa was discontinued from the United States market in May 2012.

Lutropin alfa is available under the following different brand names: Luveris.

Dosages of Lutropin Alfa:

Dosage Forms and Strengths

Discontinued from United States market May 2012

Powder for Injection

• 82.5 International Units/vial

Dosage Considerations – Should be Given as Follows:

Follicle Stimulation

• 75 International Units subcutaneously (SC) concomitantly with 75-150 International Units GONAL-f (as 2 separate injections) until follicular development; not to exceed 14 days unless signs of imminent follicular development

Administration

• See manufacturer’s package insert for the injection procedure
• Give human chorionic gonadotropin (hCG) one day after the last dose of Luveris/Gonal-f

Monitor

• Ovarian response (ovarian ultrasound, serum estradiol)

Other Indications and Uses

• Stimulation of follicular development (in conjunction with follitropin) in hypogonadotropic hypogonadal women with profound luteinizing hormone (LH) deficiency who do not have primary ovarian failure

Not applicable for use in pediatric patients

Common side effects of lutropin alfa include:

• Headache
• Fatigue
• Pain
• Breast pain
• Painful menstrual cramps
• Abdominal pain
• Constipation
• Diarrhea
• Flatulence
• Injection site reaction
• Upper respiratory tract infection

Serious side effects of lutropin alfa include:

• Arterial thrombosis
• Cyst of ovary
• Hypertrophy of ovary
• Ovarian hyperstimulation syndrome

If your doctor has directed you to use this medication, 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.

• Lutropin alfa has no listed severe interactions with other drugs.
• Lutropin alfa has no listed serious interactions with other drugs.
• Lutropin alfa has no listed moderate interactions with other drugs.
• Lutropin alfa has no listed mild interactions with other drugs.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

• This medication contains lutropin alfa. Do not take Luveris if you are allergic to lutropin alfa or any ingredients contained in this drug.
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Hypersensitivity to luteinizing hormone (LH)
• Primary ovarian failure
• Uncontrolled thyroid or adrenal dysfunction
• Uncontrolled organic intracranial cyst, e.g., pituitary tumor
• Abnormal idiopathic uterine bleeding
• Idiopathic ovarian cyst or enlargement
• Sex-hormone-dependent ovarian or reproductive tract tumors
• Pregnancy

Effects of Drug Abuse

• No information is available

Short-Term Effects

• See "What Are Side Effects Associated with Using Lutropin Alfa?”

Long-Term Effects

• See "What Are Side Effects Associated with Using Lutropin Alfa?”

Cautions

• Patients should have:
  • Serum LH less than 1.2 IU/L; serum FSH less than 5 IU/L
  • Negative progestin challenge test
• Should be carefully evaluated with regards to fertility potential, pelvic anatomy & the possibility of endometrial abnormalities
• Risk of ovarian hyperstimulation syndrome (OHSS)
• Possibility of multiple births
• Should be administered only by a physician well-versed in infertility medicine
• Luveris has not been evaluated with any other follitropin preparation besides Gonal-f

Pregnancy and Lactation

• Do not use lutropin alfa in pregnancy. The risks involved outweigh the potential benefits. Safer alternatives exist.
• Use caution if using lutropin alfa while breastfeeding. Consult your doctor.