Qulipta

/ AbbVie

The recommended dosage is 10 mg, 30 mg, or 60 mg taken orally once daily with or without food. See prescribing information for full details.

Preventive treatment of episodic migraine in adults.

Hypersensitivity to the active substance or to any of the excipients.

Hypersensitivity Reactions
Hypersensitivity reactions, including anaphylaxis, dyspnea, rash, pruritus, urticaria, and facial edema, have been reported. Hypersensitivity reactions can occur days after administration. If a hypersensitivity reaction occurs, discontinue and institute appropriate therapy
Hypertension
Development of hypertension and worsening of pre-existing hypertension have been reported following the use of CGRP antagonists in the postmarketing setting. Some of the patients who developed new-onset hypertension had risk factors for hypertension. There were cases requiring initiation of pharmacological treatment for hypertension and, in some cases, hospitalization. Hypertension may occur at any time during treatment, but was most frequently reported within 7 days of therapy initiation.
Monitor patients for new-onset hypertension, or worsening of pre-existing hypertension, and consider whether discontinuation of treatment is warranted if evaluation fails to establish an alternative etiology or blood pressure is inadequately controlled.
Raynaud’s Phenomenon
Development of Raynaud’s phenomenon and recurrence or worsening of pre-existing Raynaud’s phenomenon have been reported in the postmarketing setting following the use of CGRP antagonists. In reported cases with small molecule CGRP antagonists, symptom onset occurred a median of 1.5 days following dosing. Many of the cases reported serious outcomes, including hospitalizations and disability, generally related to debilitating pain. In most reported cases, discontinuation of the CGRP antagonist resulted in resolution of symptoms.
The drug should be discontinued if signs or symptoms of Raynaud’s phenomenon develop, and patients should be evaluated by a healthcare provider if symptoms do not resolve. Patients with a history of Raynaud’s phenomenon should be monitored for, and informed about the possibility of, worsening or recurrence of signs and symptoms.

The most common adverse reactions (incidence at least 4% and greater than placebo) are nausea, constipation, and fatigue/somnolence.
See prescribing information for more details.

CYP3A4 Inhibitors:
Coadministration with itraconazole, a strong CYP3A4 inhibitor, resulted in a significant increase in exposure of atogepant in healthy subjects.
Concomitant use of strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin) dose is 10 mg once daily. No dosage adjustment is needed with
concomitant use of moderate or weak CYP3A4 inhibitors.
CYP3A4 Inducers:
Coadministration with steady state rifampin, a strong CYP3A4 inducer, resulted in a significant decrease in exposure of atogepant in healthy subjects. Concomitant administration with moderate inducers of CYP3A4 can also result in decreased exposure of atogepant. The recommended dosage with concomitant use of strong or moderate CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John’s wort, efavirenz, etravirine) is 30 mg or 60 mg once daily.
No dosage adjustment is needed with concomitant use of weak CYP3A inducers.
OATP Inhibitors:
Coadministration with single dose rifampin, an OATP inhibitor, resulted in a significant increase in exposure of atogepant in healthy subjects . The recommended dosage of with concomitant use of OATP inhibitors (e.g., cyclosporine) is 10 mg or 30 mg once daily.

Pregnancy:

There are no adequate data on the developmental risk associated with the use of this drug in pregnant women.
In animal studies, oral administration of atogepant during the period of organogenesis (rats and rabbits) or throughout pregnancy and lactation (rats) resulted in adverse developmental effects (decreased fetal and offspring body weight in rats; increased incidence of fetal structural variations in rabbits) at exposures greater than those used clinically. See prescribing information for full details.
Lactation:
There are no data on the presence of atogepant in human milk, the effects of atogepant on the breastfed infant, or the effects of atogepant on milk production. In lactating rats, oral dosing with atogepant resulted in levels of atogepant in milk approximately 2-fold higher than that in maternal plasma. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for this drug and any potential adverse effects on the breastfed infant from this drug or from the underlying maternal condition.

Store below 25°C.
Shelf life after opening:Bottle pack: discard 59 days after first opening.