Rizatriptan (Maxalt) Contraindications / Precautions
- acute myocardial infarction
- angina
- arteriosclerosis
- basilar/hemiplegic migraine
- cardiac arrhythmias
- cardiac disease
- coronary artery disease
- hypertension
- myocardial infarction
- Wolff-Parkinson-White syndrome
- breast-feeding
- cerebrovascular disease
- children
- colitis
- diabetes mellitus
- dialysis
- driving or operating machinery
- elderly
- hepatic disease
- hypercholesterolemia
- intracranial bleeding
- MAOI therapy
- obesity
- peripheral vascular disease
- phenylketonuria
- pregnancy
- Raynaud’s disease
- renal disease
- renal failure
- renal impairment
- stroke
- tobacco smoking
Rizatriptan (Maxalt) Contraindications / Precautions
Rizatriptan can produce a transient increase in blood pressure and should not be used in cases of uncontrolled hypertension. Patients with controlled hypertension may experience mild and transient elevations in blood pressure.
Rizatriptan is contraindicated in patients with ischemic cardiac disease such as angina pectoris, vasospastic angina or Prinzmetal’s variant angina, arteriosclerosis, acute myocardial infarction, history of myocardial infarction or documented silent ischemia and in patients who have symptoms or findings consistent with ischemic or vasospastic coronary artery disease or other significant cardiac disease. It is strongly recommended that rizatriptan not be given to patients with risk factors for coronary artery disease (hypertension, hypercholesterolemia, tobacco smoking, obesity, diabetes mellitus, strong family history, female with surgical or physiological menopause, or male over 40 years) unless a cardiovascular evaluation reveals that the patient is reasonably free of coronary artery and ischemic myocardial disease or other significant underlying cardiac disease. Patients who are long-term users of rizatriptan and who have or acquire risk factors predictive of coronary artery disease should undergo periodic cardiac evaluation. For patients with risk factors predictive of coronary artery disease who are determined to have a satisfactory cardiac evaluation, the first dose of rizatriptan should be given in a controlled setting such as a clinic or physician’s office. ECG monitoring is strongly encouraged due to the possibility of asymptomatic cardiac ischemia during the time immediately following rizatriptan administration in patients with risk factors. Further, patients with symptomatic Wolff-Parkinson-White syndrome or cardiac arrhythmias associated with other cardiac accessory conduction pathway disorders not should receive rizatriptan because serious coronary vasospasm has been reported within a few hours of receiving other 5-HT1 agonists. In postmarketing surveillance of rizatriptan use, serious adverse cardiac events, including myocardial infarction, were reported within a few hours following the administration of rizatriptan.
Rizatriptan should be used with caution in patients with cerebrovascular disease, including intracranial bleeding, stroke or transient ichemic events due to the vasospastic effects of 5-HT agonists. While stroke and cerebral hemorrhage have been reported following 5-HT agonists, these events may have been present prior to administration of the drug, and the drug was mistakenly given in response to the cerebrovascular symptoms. However, patients with migraines may be at an increased risk for cerebrovascular events (e.g. stroke, hemorrhage).
Rizatriptan should be given cautiously to patients with peripheral vascular disease including Raynaud’s disease and ischemic bowel disease (colitis). 5-HT agonsits may cause vasospastic reactions leading to vascular and colonic ischemia with abdominal pain and bloody diarrhea.
Rizatriptan is contraindicated in basilar/hemiplegic migraine because safety and efficacy have not been established. Rizatriptan is not recommended for prophylaxis of migraine headaches or for the treatment of cluster headaches.
Rizatriptan is classified as FDA pregnancy category C. To date, no evidence of teratogenicity in humans has been found, but because of a lack of studies involving pregnant women, the use of rizatriptan during pregnancy is not recommended unless the benefits outweigh the risks.
Rizatriptan is excreted into the breast milk of rats at a level 5-fold or greater than maternal plasma levels. No published literature is available to guide the clinician on the use of rizatriptan in the woman nursing an infant and it is not known if rizatriptan is excreted into human breast milk. Due to a low molecular weight (roughly 269), rizatriptan will most likely enter the breast milk. Rizatriptans bioavailability is 45% and undergoes first-pass metabolism, which in theory may lessen the total amount absorbed by the infant. Rizatriptan is probably compatible with breast-feeding; however, caution should be exercised when rizatriptan is administered to breast-feeding women.
Rizatriptan should be used cautiously in patients with hepatic disease experiencing moderate hepatic insufficiency due to an increase in plasma concentrations of approximately 30%.
Rizatriptan should be used with caution in patients with significant renal disease including severe renal failure (CrCl < 2 ml/min/1.73 m2), including patients receiving dialysis. The AUC of rizatriptan in patients with renal impairment (CrCl 10 - 60 ml/min/1.73 m2) was not significantly different from healthy volunteers.
Rizatriptan is not FDA-approved for use in children. However, results from a double-blind, placebo-controlled, crossover trial demonstrate that rizatriptan was effective for the treatment of migraine attacks in pediatric patients 6 - 17 years of age. In the 96 patients who completed the study, rizatriptan 5 mg and 10 mg were significantly more effective than placebo, with the primary endpoint attained in 74% and 73% of patients following the first and second rizatriptan treatment phases versus 36% during the placebo phase. Side effects were minimal, with no serious adverse events reported (see Adverse Reactions).
Rizatriptan is contraindicated in patients with serotonin hypersensitivity or sensitivity to any of the components of the tablets.
Patients with phenylketonuria should be warned that Maxalt-MLT™ disintegrating tablets contain phenylalanine. Each 5 mg disintegrating tablet contains 1.05 mg phenylalanine and each 10 mg disintegrating tablet contains 2.1 mg phenylalanine.
Patients should be advised not to driving or operating machinery until they know how rizatriptan will affect them.
Rizatriptan should be used with caution in elderly patients with migraine; the manufacturer recommends against use in elderly patients > 71 years of age as a result of limited data. Elderly patients are more likely to have decreased hepatic function, more pronounced blood pressure increases, and are at a higher risk for coronary artery disease (CAD) than younger adults. The pharmacokinetics of rizatriptan are similar in elderly volunteers compared younger individuals. There are no observed differences in the safety and tolerability between the two populations; however, insufficient numbers of elderly patients receiving rizatriptan have been studied (n=17).
Whenever possible, do not give serotonin-receptor agonists concurrently with MAOI therapy (see Drug Interactions).
[ Last revised: 9/21/2006 4:54:00 PM ]
References
. Maxalt® and Maxalt-MLT® (rizatriptan) package insert. Whitehouse Station, NJ: Merck & Co., Inc.; 2006 Jan.
. Drugs in Pregnancy and Lactation. A Reference Guide to Fetal and Neonatal Risk. Briggs GG, Freeman RK, Yaffe SJ, (eds.) 7th ed., Philadelphia. PA. Lippincott Williams and Wilkins. 2005; 1430.
. Ahonen K, Hamalainen ML, Eerola M, et al. A randomized trial of rizatriptan in migraine attacks in children. Neurology 2006;67:1 - 6.
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