Luveris Side Effects
Generic Name: Lutropin Alfa
Please note - some side effects for Luveris may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
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For the consumer For the professional
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Side Effects of Luveris - for the consumer
Luveris
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Luveris:
Seek medical attention right away if any of these SEVERE side effects occur when using Luveris:Constipation; diarrhea; gas; headache; nausea; pain, redness, or swelling at the injection site; tiredness.
TopSevere allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); breast pain; decrease in the amount of urine produced; pain, tenderness, redness, or swelling of the leg; severe pelvic pain; severe or persistent nausea, vomiting, or diarrhea; shortness of breath; stomach pain or swelling; unexplained weight gain.
For the professional
Luveris
The safety of Luveris® was examined in six clinical studies that treated 170 infertile women with hypogonadotropic hypogonadism of whom 152 received Luveris® and Gonal-f® in 283 treatment cycles. Adverse events reported by ≥2% of patients (regardless of causality) treated with any dose of Luveris® (25, 75, 150, 225 IU) are listed in Table 7.
| 0 IU Luveris®& Gonal-f® | 75 IU Luveris®& Gonal-f® | All doses of Luveris®& Gonal-f® | ||
|---|---|---|---|---|
| Patients (n=43) | Patients (n=118) | Patients (n=152) | ||
| n (%) | n (%) | n (%) | ||
| (a) Study 6905 was a randomized, open-label, dose-finding study to assess the efficacy and safety of Luveris® administered with 150 IU Gonal-f® for induction of follicular development in HH women. | ||||
| (b) Study 7798 was an uncontrolled, multicenter, dose-finding study to assess the efficacy and safety of Luveris® administered with 150 IU Gonal-f® for induction of follicular development in LH and FSH deficient anovulatory women in Germany. | ||||
| (c) Study 8297 was an uncontrolled, multicenter, dose-finding study to assess the efficacy and safety of Luveris® administered with 150 IU Gonal-f® for induction of follicular development in HH women in Spain. | ||||
| Patients With Events | 20 (46.5) | 50 (42.4) | 72 (47.4) | |
| Headache | 2 (4.7) | 12 (10.2) | 15 (9.9) | |
| Nausea | 0 | 8 (6.8) | 11 (7.2) | |
| Ovarian Hyperstimulation | 1 (2.3) | 7 (5.9) | 9 (5.9) | |
| Breast Pain Female | 4 (9.3) | 6 (5.1) | 9 (5.9) | |
| Abdominal Pain | 5 (11.6) | 6 (5.1) | 13 (8.6) | |
| Ovarian Cyst | 4 (9.3) | 6 (5.1) | 8 (5.3) | |
| Flatulence | 3 (7.0) | 5 (4.2) | 6 (3.9) | |
| Injection Site Reaction | 2 (4.7) | 4 (3.4) | 6 (3.9) | |
| Dysmenorrhoea | 1 (2.3) | 2 (1.7) | 4 (2.6) | |
| Ovarian Disorder | 0 | 2 (1.7) | 3 (2.0) | |
| Diarrhoea | 1 (2.3) | 3 (2.5) | 3 (2.0) | |
| Constipation | 0 | 3 (2.5) | 3 (2.0) | |
| Pain | 3 (7.0) | 3 (2.5) | 6 (3.9) | |
| Fatigue | 0 | 3 (2.5) | 5 (3.3) | |
| Upper Resp Tract Infection | 2 (4.7) | 1 (0.8) | 3 (2.0) | |
The following medical events have been reported subsequent to pregnancies resulting from administration of gonadotropins for ovulation induction in controlled clinical studies:
Spontaneous Abortion
Ectopic Pregnancy
Premature Labor
Postpartum Fever
Congenital abnormalities
There is no evidence that use of any gonadotropin drug product for treatment of infertility is associated with an increased risk of congenital malformations.
The following adverse reactions have been previously reported during menotropin therapy:
Pulmonary and vascular complications
Adnexal torsion (as a complication of ovarian enlargement)
Mild to moderate ovarian enlargement
Hemoperitoneum
There have been infrequent reports of ovarian neoplasms, both benign and malignant, in women who have undergone multiple drug regimens for ovulation induction; however, a causal relationship has not been established.
TopMore resources:
Luveris - Includes detailed dosage instructions.
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