Frova

Myocardial Ischemia, Myocardial Infarction, and Prinzmetal Angina

• Frova is contraindicated in patients with ischemic or vasospastic coronary artery disease (CAD). Rare reports of serious cardiac adverse reactions, including acute myocardial infarction, have occurred within a few hours following administration.

• Prior to treatment, perform a cardiovascular evaluation in triptan-naïve patients who have multiple cardiovascular risk factors (eg, increased age, diabetes, hypertension, smoking, obesity, strong family history of CAD). Do not administer if there is evidence of CAD or coronary artery vasospasm (see Contraindications). For patients with multiple cardiovascular risk factors who have a negative cardiovascular evaluation, consider administering the first Frova dose in a medically-supervised setting and performing an electrocardiogram (ECG) immediately following administration and consider periodic cardiovascular evaluation in intermittent long-term users of Frova. 

Arrhythmias

• Life-threatening disturbances of cardiac rhythm including ventricular tachycardia and ventricular fibrillation leading to death have been reported within a few hours following the administration of 5-HT1 agonists. Discontinue Frova if these disturbances occur. 

• Frova is contraindicated in patients with Wolff-Parkinson-White Syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders.

Chest, Throat, Neck and Jaw Pain/Tightness/Pressure

• Perform a cardiac evaluation if patients who are at high cardiac risk experience sensations of tightness, pain, and pressure in the chest, throat, neck, and jaw after treatment with Frova. 

• Frova is contraindicated in patients with CAD or Prinzmetal’s variant angina.

Cerebrovascular Events

• Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred in patients treated with 5-HT1 agonists, and some have resulted in fatalities. 

• Exclude other potentially serious neurological conditions before treating headaches in patients not previously diagnosed as migraineurs, and in migraineurs who present with symptoms atypical for migraine. Frova is contraindicated in patients with a history of stroke or transient ischemic attack.

Other Vasospasm Reactions

• May cause non-coronary vasospastic reactions, such as peripheral vascular ischemia, gastrointestinal vascular ischemia and infarction (presenting with abdominal pain and bloody diarrhea), splenic infarction, and Raynaud’s syndrome. 

• Rule out a vasospastic reaction before receiving additional Frova doses in patients who experience symptoms or signs suggestive of a non-coronary vasospastic reaction following the use of any 5-HT1 agonist.

• Reports of transient and permanent blindness and significant partial vision loss have been reported with the use of 5-HT1 agonists. A causal relationship between visual  disorders and the use of 5-HT1 agonists has not been clearly established. 

Medication Overuse Headache

• Overuse of acute migraine drugs (eg, ergotamine, triptans, opioids, or a combination of drugs for 10 or more days per month) may lead to exacerbation of headache (medication overuse headache).

• Medication overuse headache may present as migraine-like daily headaches or as a marked increase in frequency of migraine attacks. 

• May be necessary to detoxify patients, including withdrawal of the overused drugs, and treatment of withdrawal symptoms (which often includes a transient worsening of headache). 

Serotonin Syndrome

• The onset of symptoms usually rapidly occurs within minutes to hours of receiving a new or a greater dose of a serotonergic medication. 

• Discontinue if serotonin syndrome is suspected.

Increase in Blood Pressure

• Significant elevations in blood pressure, including hypertensive crisis with acute impairment of organ systems, have been reported in patients treated with 5-HT1 agonists including patients without a history of hypertension. 

• Monitor blood pressure. Frova is contraindicated in patients with uncontrolled hypertension.