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Nymalize

"On May 10, the U.S. Food and Drug Administration approved Nymalize, a new nimodipine oral solution, to treat patients experiencing symptoms resulting from ruptured blood vessels in the brain (subarachnoid hemorrhage). Nimodipine previously was av"...

Nymalize

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Hypotension

Blood pressure should be carefully monitored during treatment with NYMALIZE. In clinical studies of patients with subarachnoid hemorrhage, about 5% of nimodipine-treated patients compared to 1% of placebo-treated patients had hypotension and about 1% of nimodipine-treated patients left the study because of this. [see ADVERSE REACTIONS].

Possible Increased Risk of Adverse Reactions in Patients with Cirrhosis

Given that the plasma levels of nimodipine are increased in patients with cirrhosis, these patients are at higher risk of adverse reactions. Therefore, monitor blood pressure and pulse rate closely and administer a lower dosage [see DOSAGE AND ADMINISTRATION, CLINICAL PHARMACOLOGY].

Possible Increased Risk of Hypotension with Strong CYP3A4 Inhibitors

Concomitant use of strong inhibitors of CYP3A4, such as some macrolide antibiotics (e.g., clarithromycin, telithromycin), some HIV protease inhibitors (e.g., indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (e.g., boceprevir, telaprevir), some azole antimycotics (e.g., ketoconazole, itraconazole, posaconazole, voriconazole), conivaptan, delaviridine, and nefazadone with nimodipine should generally be avoided because of a risk of significant hypotension [see DRUG INTERACTIONS].

Possible Reduced Efficacy with Strong CYP3A4 Inducers

Concomitant use of strong CYP3A4 inducers (e.g. carbamazepine, phenobarbital, phenytoin, rifampin, St John's wort) and nimodipine should generally be avoided, as nimodipine plasma concentration and efficacy may be significantly reduced [see DRUG INTERACTIONS].

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

In a two-year study in rat, the incidences of adenocarcinoma of the uterus and Leydig cell adenoma of the testes were increased at 1800 ppm nimodipine in the diet (approximately 90-120 mg/kg/day). The increases were not statistically significant, however, and the higher rates were within the historical control range for these tumors. Nimodipine was found not to be carcinogenic in a 91-week mouse study, but the high dose of 1800 ppm nimodipine in the diet (approximately 550-775 mg/kg/day) was associated with an increased mortality rate.

Mutagenesis

Mutagenicity studies, including the Ames, micronucleus, and dominant lethal assays, were negative.

Impairment of Fertility

Nimodipine did not impair the fertility and general reproductive performance of male and female rats following oral doses of up to 30 mg/kg/day when administered prior to mating and continuing in females to day 7 of pregnancy. This dose in a rat is similar to a clinical dose of 60 mg every 4 hours in a 60 kg patient, on a body surface area (mg/m²) basis.

Use In Specific Populations

Pregnancy

Pregnancy Category C

There are no adequate and well controlled studies in pregnant women to directly assess the effect on human fetuses. NYMALIZE should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nimodipine has been shown to have a teratogenic effect in two studies in rabbit. In one study, incidences of malformations and stunted fetuses were increased at oral doses of 1 mg/kg/day and 10 mg/kg/day administered throughout organogenesis but not at 3 mg/kg/day. In the second study, an increased incidence of stunted fetuses was seen at 1 mg/kg/day but not at higher doses (3 mg/kg/day and 10 mg/kg/day). Nimodipine was embryotoxic, causing resorption and stunted growth of fetuses in rats at 100 mg/kg/day administered orally throughout organogenesis. In two other rat studies, doses of 30 mg/kg/day nimodipine administered orally throughout organogenesis and continued until sacrifice (day 20 of pregnancy or day 21 postpartum) were associated with higher incidences of skeletal variation, stunted fetuses, and stillbirths but no malformations.

Nursing Mothers

Nimodipine and/or its metabolites have been detected in rat milk at concentrations much higher than in maternal plasma. It is not known whether the drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from NYMALIZE, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clinical studies of nimodipine did not include sufficient numbers of subjects aged 65 and over to determine whether they had a different clinical response than younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dosing in elderly patients should be cautious, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy [see CLINICAL PHARMACOLOGY].

Last reviewed on RxList: 5/23/2013
This monograph has been modified to include the generic and brand name in many instances.

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