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ALNIDITAN
Generic Name: ALNIDITAN
ABSTRACT -
Alniditan, also known as R-91274, is an investigational non-indole serotonin 5-HT1B/1D receptor agonist that was studied as an acute antimigraine medicine. Like triptans, it was intended to relieve migraine by acting on cranial serotonergic pathways, but it was not developed into a routinely marketed medicine. Use is limited to research or historical clinical-study contexts.
DOSAGE -
- Alniditan does not have an approved routine dosage regimen.
- Historical clinical trials evaluated protocol-defined oral or subcutaneous dosing schedules.
- Dose, route, repeat dosing, cardiovascular evaluation, and monitoring must follow a clinical-study protocol if used in research.
- Patients should use approved migraine therapies instead of alniditan unless enrolled in an authorized study.
SIDE EFFECTS–
- Reported or potential side effects may include:
- Head pressure or tightness
- Paresthesia or tingling
- Hot flushes
- Dizziness
- Nausea
- Somnolence
- Chest, throat, neck, or jaw pressure sensations
- Changes in blood pressure or heart rate
- Injection-site reaction when administered subcutaneously
- Fatigue
- Allergic or hypersensitivity reactions
ALLRGIC REACTIONS–
(These symptoms may indicate an allergic reaction to the drug.)
- Skin rash
- Itching
- Hives
- Swelling of face, lips, tongue, or throat
- Difficulty breathing
- Wheezing
- Severe dizziness
- Rapid heartbeat
- Chest tightness
- Anaphylaxis
- Severe hypersensitivity reactions
DRUG INTERACTIONS–
- The interaction profile may include or require caution with:
- Other triptans or 5-HT1B/1D agonists
- Ergotamine or dihydroergotamine
- SSRIs, SNRIs, tricyclic antidepressants, MAO inhibitors, or St. John's wort
- Vasoconstrictive medicines
- Antihypertensive medicines or cardiovascular drugs
- Other investigational migraine medicines
- Patients should inform healthcare providers about all prescription medicines, non-prescription medicines, herbal products, and supplements being used.
PREAUTIONS–
- Use only in a research or specialist-supervised setting.
- Assess cardiovascular risk, migraine diagnosis, blood pressure, stroke history, and concomitant serotonergic medicines before use.
- Avoid use in patients with coronary artery disease, stroke, transient ischemic attack, peripheral vascular disease, uncontrolled hypertension, or hemiplegic/basilar migraine unless a protocol specifically permits it.
- Monitor for chest symptoms, neurologic symptoms, blood-pressure changes, and serotonin toxicity.
- Pregnancy, breastfeeding, and pediatric safety have not been established.
WARNINGS –
- Alniditan is investigational and not a routine marketed migraine treatment.
- Serotonin agonists may cause serious cardiovascular or cerebrovascular events in susceptible patients.
- Chest pain, shortness of breath, neurologic deficit, severe hypertension, fainting, or sudden severe headache requires emergency care.
- Do not combine with other vasoconstrictive migraine medicines unless a specialist protocol directs it.
- Keep out of reach of children.
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