Note: This document contains side effect information about lutropin alfa. Some dosage forms listed on this page may not apply to the brand name Luveris.

Applies to lutropin alfa: subcutaneous powder for injection.

General

The most commonly reported adverse events reported have included headache, pelvic and abdominal pain, nausea, injection site reactions, and mild or moderate ovarian hyperstimulation syndrome (OHSS).^[Ref]

Endocrine

Common (1% to 10%): Ovarian hyper-stimulation syndrome (OHSS), ovarian cyst, breast pain, pelvic pain

Frequency not reported: Abortion, breast enlargement, endometrial disorder, genital edema, hemorrhage in pregnancy, leucorrhoea, pelvic pain, pelvic congestion, ectopic pregnancy, premenstrual tension, uterine disorder not otherwise specified, uterine spasm, vaginal candidiasis, vaginal hemorrhage, vaginitis

Local

Common (1% to 10%): Injection site reactions^[Ref]

During clinical trials, 7.4% of patients reported mild and moderate injection site reactions consisting of bruising, pain, redness, itching, or swelling; there were no reports of severe injection site reactions^[Ref]

Genitourinary

Common (1% to 10%): Dysmenorrhea

Frequency not reported: Dysuria, micturition frequency change^[Ref]

Gastrointestinal

Common (1% to 10%): Abdominal pain, abdominal discomfort, nausea, vomiting, diarrhea, flatulence, constipation,

Frequency not reported: Tooth caries^[Ref]

Cardiovascular

Very rare (less than 0.01%): Thromboembolism

Frequency not reported: Vasodilation^[Ref]

Musculoskeletal

Frequency not reported: Asthenia, back pain, leg cramps, leg pain, skeletal pain^[Ref]

Nervous system

Common (1% to 10%): Headache

Frequency not reported: Hyperkinesia, dizziness^[Ref]

Respiratory

Frequency not reported: Cough, dyspnea, pharyngitis, rhinitis^[Ref]

Hypersensitivity

Mild to severe hypersensitivity reactions including anaphylactic reactions and shock have been reported.

Very rare (less than 0.01%): Hypersensitivity reactions

Immunologic

Frequency not reported: Herpes simplex, infection, influenza-like symptoms, Klebsiella

Ocular

Frequency not reported: Conjunctivitis

Psychiatric

Frequency not reported: Anxiety, depression, insomnia, nervousness, somnolence

Oncologic

There have been reports of ovarian and other reproductive system neoplasms, both benign and malignant, in women who have undergone multiple treatment regimens for infertility. It has not been established whether or not treatment with gonadotropins increases the risk of these tumors in infertile women.

Frequency not reported: Neoplasms

Other

Frequency not reported: Fever, not otherwise specified; fever

Dermatologic

Frequency not reported: Acne, nail disorder, rash dry skin