Almotriptan use in specific populations

Almotriptan
AXERT® FDA Package Insert
Indications and Usage
Dosage and Administration
Dosage Forms and Strengths
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Overdosage
Description
Clinical Pharmacology
Nonclinical Toxicology
Clinical Studies
How Supplied/Storage and Handling
Patient Counseling Information
Labels and Packages
Clinical Trials on Almotriptan
ClinicalTrials.gov

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Pratik Bahekar, MBBS [2]

Use in Specific Populations

• Pregnancy: based on animal data, may cause fetal harm
• Nursing mothers: use Almotriptan with caution
• Pediatric use: Almotriptan has not been studied in children under 12 years
• Geriatric use: insufficient safety and efficacy data; use with caution, usually starting with the 6.25 mg dose
• Hepatic impairment: use single 6.25 mg tablet as a starting dose; maximum daily dose 12.5 mg
• Severe renal impairment: use single 6.25 mg tablet as a starting dose; maximum daily dose 12.5 mg

Pregnancy

Pregnancy Category C

In animal studies, almotriptan produced developmental toxicity (increased embryolethality and fetal skeletal variations, and decreased offspring body weight) at doses greater than those used clinically. There are no adequate and well-controlled studies in pregnant women; therefore, Almotriptan (almotriptan malate) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

When almotriptan (125, 250, 500, or 1000 mg/kg/day) was administered orally to pregnant rats throughout the period of organogenesis, increased incidences of fetal skeletal variations (decreased ossification) were noted at a dose of 250 mg/kg/day or greater and an increase in embryolethality was seen at the highest dose. The no-effect dose for embryo-fetal developmental toxicity in rats (125 mg/kg/day) is approximately 100 times the maximum recommended human dose (MRHD) of 25 mg/day on a body surface area (mg/m2) basis. Similar studies in pregnant rabbits conducted with almotriptan (oral doses of 5, 20, or 60 mg/kg/day) demonstrated increases in embryolethality at the highest dose. The no-effect dose for embryo-fetal developmental toxicity in rabbits (20 mg/kg/day) is approximately 15 times the MRHD on a mg/m2 basis. When almotriptan (25, 100, or 400 mg/kg/day) was administered orally to rats throughout the periods of gestation and lactation, gestation length was increased and litter size and offspring body weight were decreased at the highest dose. The decrease in pup weight persisted throughout lactation. The no-effect dose in this study (100 mg/kg/day) is 40 times the MRHD on a mg/m2 basis.

Labor and Delivery

The effect of Almotriptan on labor and delivery in humans is unknown.

Nursing Mothers

It is not known whether almotriptan is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Almotriptan is administered to a nursing woman. Levels of almotriptan in rat milk were up to 7 times higher than in rat plasma.

Pediatric Use

Safety and efficacy of Almotriptan in pediatric patients under the age of 12 years have not been established. The pharmacokinetics, efficacy, and safety of Almotriptan have been evaluated in adolescent patients, age 12 to 17 years [see Clinical Pharmacology (12.3) and Clinical Studies (14.2)].

In a clinical study, Almotriptan 6.25 mg and 12.5 mg were found to be effective for the relief of migraine headache pain in adolescent patients age 12 to 17 years. Efficacy on migraine-associated symptoms (nausea, photophobia, and phonophobia) was not established. The most common adverse reactions (incidence of ≥1%) associated with Almotriptantreatment were dizziness, somnolence, headache, paresthesia, nausea, and vomiting [see Adverse Reactions (6.1)]. The safety and tolerability profile of Almotriptan treatment in adolescents is similar to the profile observed in adults.

Postmarketing experience with other triptans include a limited number of reports that describe pediatric patients who have experienced clinically serious adverse events that are similar in nature to those reported rarely in adults.

Geriatric Use

Clinical studies of Almotriptan did not include sufficient numbers of subjects age 65 and over to determine whether they respond differently from younger subjects. Clearance of almotriptan was lower in elderly volunteers than in younger individuals, but there were no observed differences in the safety and tolerability between the two populations [seeClinical Pharmacology (12.3)]. In general, dose selection for an elderly patient should be cautious, usually starting at the low dose, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. The recommended dose of Almotriptan for elderly patients with normal renal function for their age is the same as that recommended for younger adults.

Hepatic Impairment

The recommended starting dose of Almotriptan in patients with hepatic impairment is 6.25 mg. The maximum daily dose should not exceed 12.5 mg over a 24-hour period [seeDosage and Administration (2.2) and Clinical Pharmacology (12.3)].

Renal Impairment

The recommended starting dose of Almotriptan in patients with severe renal impairment is 6.25 mg. The maximum daily dose should not exceed 12.5 mg over a 24-hour period [seeDosage and Administration (2.3) and Clinical Pharmacology (12.3)].