Wakix 17.8mg Tablets

Pitolisant is a selective histamine-3 (H3) receptor antagonist/inverse agonist. By blocking presynaptic H3 autoreceptors, it increases the synthesis and release of histamine from histaminergic neurons in the brain. Histamine is a wake-promoting neurotransmitter. Pitolisant also modulates the activity of other neurotransmitter systems (e.g., acetylcholine, norepinephrine, dopamine) indirectly through its effects on histamine neurons.

Serious Side Effects: Seek Medical Help Immediately

Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Hallucinations (seeing or hearing things that are not there)
Abnormal heartbeat (prolonged QT interval), which can cause:
+ Fast heartbeat
+ Irregular heartbeat
+ Fainting (passing out)

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:

Headache
Trouble sleeping
Upset stomach
Anxiety
Signs of a common cold
* Back, joint, muscle, neck, arm, or leg pain

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
Existing health conditions, including kidney disease or liver disease.
Electrolyte imbalances, such as low magnesium or potassium levels, or a slow heartbeat.
A history of abnormal heart rhythms, including a prolonged QT interval on an electrocardiogram (ECG).
Use of medications that may cause abnormal heart rhythms, such as those that prolong the QT interval. There are many medications that can have this effect, so ask your doctor or pharmacist if you are unsure.
Concurrent use of certain medications, including clomipramine, diphenhydramine, imipramine, mirtazapine, pheniramine, or promethazine.

Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to disclose all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you may have. Your doctor and pharmacist will help determine whether it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor first.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. The full effect of this drug may not be apparent until up to 8 weeks after starting treatment.

If you are using birth control pills or other hormone-based birth control methods, they may be less effective in preventing pregnancy while taking this medication. To minimize the risk of unintended pregnancy, it is recommended to use an additional form of birth control, such as a condom, during treatment with this drug and for 3 weeks after discontinuing it.

If you are pregnant, planning to become pregnant, or are breast-feeding, you must consult your doctor to discuss the potential benefits and risks of this medication to both you and your baby. This will enable you to make an informed decision about your treatment.

• Strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, quinidine, bupropion): Reduce Wakix dose by half.
• Strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's Wort): Avoid coadministration or consider alternative.

• Moderate CYP2D6 inhibitors (e.g., duloxetine, terbinafine): Consider dose reduction.
• Moderate CYP3A4 inducers (e.g., efavirenz, bosentan): Consider dose adjustment or alternative.
• Drugs that prolong QT interval (e.g., Class IA and Class III antiarrhythmics, antipsychotics, macrolide antibiotics, fluoroquinolones): Avoid coadministration if possible, monitor ECG if necessary.

• CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): No dose adjustment needed, but monitor for increased adverse effects.
• CYP2D6 substrates (e.g., metoprolol, dextromethorphan): Pitolisant may increase exposure of these drugs; monitor.

• Excessive daytime sleepiness (EDS)
• Cataplexy episodes (if applicable)
• Insomnia or difficulty sleeping
• Nausea, stomach upset
• Headache
• Anxiety, irritability
• Dizziness
• Palpitations or irregular heartbeat (report immediately)
• Signs of allergic reaction (rash, swelling, difficulty breathing)

Limited human data on pitolisant use in pregnant women are insufficient to inform a drug-associated risk for major birth defects or miscarriage. In animal reproduction studies, oral administration of pitolisant to pregnant rats and rabbits during organogenesis resulted in adverse developmental effects (embryo-fetal mortality, reduced fetal body weights, and skeletal variations) at clinically relevant exposures. Use only if the potential benefit justifies the potential risk to the fetus.

There are no data on the presence of pitolisant in human milk, the effects on the breastfed infant, or the effects on milk production. Pitolisant was present in the milk of lactating rats. Because of the potential for serious adverse reactions in breastfed infants, including QTc prolongation, advise women not to breastfeed during treatment with Wakix and for 1 day after the final dose.

Safety and effectiveness have not been established in pediatric patients (under 18 years of age).

No overall differences in safety or effectiveness were observed between elderly patients and younger adult patients, but greater sensitivity of some older individuals cannot be ruled out. Dosage adjustment based on renal function may be necessary in elderly patients.

• Wakix is a non-scheduled medication for narcolepsy, offering an alternative to controlled substances.
• Titration is crucial for optimizing efficacy and tolerability; patients start low and go slow.
• Monitor QTc interval, especially in patients with pre-existing cardiac conditions or those on other QTc-prolonging drugs.
• Hepatic and renal impairment require significant dose adjustments; Wakix is not recommended in severe hepatic impairment or ESRD.
• Patients should be advised about potential for insomnia, anxiety, and headache, especially during titration.
• Consider drug interactions with CYP2D6 inhibitors and CYP3A4 inducers, as these can significantly alter pitolisant exposure.

• Modafinil
• Armodafinil
• Solriamfetol
• Sodium oxybate (Xyrem, Xywav)
• Methylphenidate
• Amphetamines

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more details. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider for clarification. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When reporting the incident, be prepared to provide information about the medication taken, the amount, and the time it occurred.