WAKIX PrescriptionFrequently Asked Questions About Narcolepsy and WAKIX
Learn more about WAKIX and the frequently asked questions surrounding narcolepsy.
Frequently Asked Questions
Evaluating for ongoing symptoms
Q.What can excessive daytime sleepiness (EDS) in narcolepsy look like?
A.
Because all people with narcolepsy have chronic daily EDS, it is important to be aware of the different ways EDS can manifest. In addition to unintended lapses into sleep, EDS can also manifest as an inability to stay alert during the day or lapses in concentration. Patients with narcolepsy experience an irrepressible need to sleep but may use vague terms to describe their EDS, such as “tired,” “fatigued,” or “having no energy.”1,2
Q.What can cataplexy look like?
A.
Cataplexy commonly affects facial muscles, with abrupt interruption of the smile or facial expression.3 Some examples of cataplexy include drooping of the eyelids, muscle weakness in the face or neck, mouth opening, tongue sticking out, and facial jerks/grimaces.1,3 Patients may describe their cataplexy as “losing muscle control,” “clumsiness,” or “loss of grip.”4-6 Cataplexy may develop years after the onset of EDS and manifestations may differ widely among patients.1,7 Use this guide to help uncover EDS and cataplexy in your patients with narcolepsy.
Understanding more about WAKIX
Q.How is WAKIX thought to work?
A.
The mechanism of action of WAKIX in excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy is unclear; however, its efficacy could be mediated through its activity at histamine 3 (H3) receptors. Watch this video to understand how WAKIX is thought to work.
Q.What symptoms of narcolepsy does WAKIX treat?
A.
WAKIX is indicated for the treatment of EDS or cataplexy in adult patients with narcolepsy.
Q.Do patients have to have both EDS and cataplexy to take WAKIX?
A.
No, patients do not have to have both EDS and cataplexy to take WAKIX.
Q.Is WAKIX a stimulant?
A.
No, WAKIX is not a stimulant.
Q.Is WAKIX a controlled substance?
A.
No, WAKIX is not a controlled substance; it is the first and only FDA-approved nonscheduled treatment for EDS or cataplexy in narcolepsy.
Considering WAKIX for your patient
Q.Is there a pregnancy exposure registry for WAKIX?
A.
There is a pregnancy exposure registry that monitors pregnancy outcomes in women who are exposed to WAKIX during pregnancy. Patients should be encouraged to enroll in the WAKIX pregnancy registry if they become pregnant. To enroll or obtain information from the registry, patients can call 1-800-833-7460.
Q.Can WAKIX be taken with hormonal contraceptives?
A.
The effectiveness of hormonal contraceptives may be reduced when used with WAKIX and effectiveness may be reduced for 21 days after discontinuation of treatment. Advise patients to use an alternative nonhormonal contraceptive method during treatment with WAKIX and for at least 21 days after discontinuation of treatment.
Q.Is a baseline electrocardiogram (ECG) required prior to starting treatment with WAKIX?
A.
The Prescribing Information for WAKIX does not have a requirement for a baseline ECG prior to starting WAKIX. WAKIX increases the QT interval; the highest recommended dose (35.6 mg) led to a QTc increase of 4.2 msec. Exposures that were 3.8-fold higher than achieved at the highest recommended dose led to a QTc increase of 16 msec (mean). Avoid use of WAKIX in patients with known QT prolongation; in patients with a history of cardiac arrhythmias or other risk factors for QT interval prolongation; or in combination with other drugs known to prolong the QT interval. Monitor patients with hepatic or renal impairment for increased QTc. Dosage modification is recommended in patients with moderate hepatic impairment and moderate or severe renal impairment. WAKIX is contraindicated in patients with severe hepatic impairment and not recommended in patients with end-stage renal disease (ESRD). See Full Prescribing Information for more information.
Q.What are common adverse reactions with WAKIX?
A.
In the placebo-controlled clinical studies conducted in patients with narcolepsy with or without cataplexy, the most common adverse reactions (occurring in ≥5% of patients and at least twice the rate of placebo) with the use of WAKIX were insomnia (6%), nausea (6%), and anxiety (5%). Additional adverse reactions occurring in ≥2% of WAKIX-treated patients and more frequently than in placebo-treated patients were headache, upper respiratory tract infection, musculoskeletal pain, heart rate increased, hallucinations, irritability, abdominal pain, sleep disturbance, decreased appetite, cataplexy, dry mouth, and rash. View the safety profile of WAKIX in clinical studies.
Dosing and titrating WAKIX
Q.How should WAKIX be taken?
A.
WAKIX should be taken once daily in the morning upon wakening and is titrated to the recommended dose range of 17.8 mg to 35.6 mg. See questions below and Full Prescribing Information. After initiating treatment with WAKIX, it’s important to regularly assess patients for symptom improvement and tolerability. The dose of WAKIX may be adjusted based on tolerability. View the recommended dosing and titration of WAKIX.
Q.What is the recommended titration for WAKIX?
A.
Initiate at 8.9 mg (two 4.45-mg tablets) once daily for Week 1, increase to 17.8 mg (one 17.8-mg tablet) once daily for Week 2, and may increase to the maximum recommended dosage of 35.6 mg (two 17.8-mg tablets) once daily for Week 3. Dosing modifications are recommended for some patients. See question below and Full Prescribing Information. Watch this video to understand WAKIX dosing and titration.
Q.Are there any dosing modifications for WAKIX?
A.
Yes, dosing modifications are recommended for patients with moderate hepatic impairment, patients with moderate or severe renal impairment, patients known to be poor CYP2D6 metabolizers, and patients receiving concomitant strong CYP2D6 inhibitors or strong CYP3A4 inducers. See Full Prescribing Information for recommended dosage and titration. Use this tool to identify drug interactions and recommendations for dosing WAKIX with other medications.
Q.Are there any pharmacokinetic (PK) interactions with WAKIX and other narcolepsy medications?
A.
In a clinical PK study to evaluate the concomitant use of WAKIX with modafinil or sodium oxybate, WAKIX had no effect on the PK of modafinil or sodium oxybate, and these agents had no clinically relevant effect on the PK of WAKIX.
Setting your patients’ expectations
Q.What are some important things to discuss with patients when initiating treatment with WAKIX?
A.
Before your patient begins treatment with WAKIX:
Before your patient begins treatment with WAKIX:
- Explain that WAKIX should be taken once daily, not on an as-needed basis. WAKIX is to be taken in the morning as soon as they wake up
- Remind patients not to split up their daily dose of WAKIX or take it later in the day
- Clarify that WAKIX will be titrated to the effective dosage
- Explain that WAKIX is not a stimulant
- Treatments work differently; remind patients that WAKIX may take time to work
- Advise about possible side effects and taking WAKIX with other medications
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Share this brochure with your patients so they can learn more about WAKIX
- Remind patients not to split up their daily dose of WAKIX or take it later in the day
- Treatments work differently; remind patients that WAKIX may take time to work
Q.When can patients expect to see a clinical response with WAKIX?
A.