Qulipta 10mg Tablets

Atogepant is a calcitonin gene-related peptide (CGRP) receptor antagonist. It works by blocking the binding of CGRP to its receptor, thereby inhibiting CGRP-mediated signaling. CGRP is a neuropeptide that plays a key role in nociceptive transmission and is implicated in the pathophysiology of migraine.

Serious Side Effects: Seek Medical Attention 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 help 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, or swelling of the mouth, face, lips, tongue, or throat.

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. Contact your doctor or seek medical help if you experience any of the following side effects or if they bother you or do not go away:
- Upset stomach
- Constipation
- Feeling sleepy
- Feeling tired or weak

Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, 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 you experienced, including any symptoms that occurred.
If you have a history of kidney disease or liver disease, as these conditions may affect how your body processes this medication.

This list is not exhaustive, and it is crucial to discuss all your health concerns with your doctor. To ensure safe treatment, please disclose all the following information to your doctor and pharmacist:
A complete list of all prescription and over-the-counter medications you are taking, including natural products and vitamins.
Any health problems you are experiencing or have experienced in the past.

Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe to do so. This will help prevent potential interactions and ensure the best possible treatment outcome.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you regularly consume grapefruit juice or eat grapefruit, discuss this with your doctor, as it may interact with your treatment. Additionally, numerous medications can interact with this drug, so it is crucial that your doctor and pharmacist are aware of all the other medications you are taking, especially if you are using this medication to treat chronic migraine. Some medications should not be taken concurrently with this drug, and your healthcare team needs to be aware of your full medication regimen. If you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks of this medication to both you and your baby.

• Strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's wort): Co-administration is contraindicated due to significant reduction in atogepant exposure, leading to loss of efficacy.

• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir): Reduce atogepant dose to 10 mg once daily.
• Moderate CYP3A4 inducers (e.g., bosentan, efavirenz, etravirine, modafinil, nafcillin): Avoid co-administration due to potential for reduced atogepant exposure and loss of efficacy.

• Weak CYP3A4 inhibitors/inducers: No dosage adjustment needed.
• OATP inhibitors (e.g., cyclosporine, quinidine): No dosage adjustment needed, but monitor for increased atogepant exposure.

• Nausea
• Constipation
• Fatigue
• Somnolence
• Weight decrease
• Elevated liver enzymes (rare, but monitor for symptoms of liver injury)

There are no adequate and well-controlled studies of Qulipta in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. A pregnancy exposure registry exists for women exposed to Qulipta during pregnancy.

It is unknown if atogepant is excreted in human milk. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Qulipta and any potential adverse effects on the breastfed infant from Qulipta or from the underlying maternal condition. Atogepant is present in the milk of lactating rats.

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

No overall differences in effectiveness or safety were observed between elderly patients (65 years and older) and younger adult patients. No dosage adjustment is required based on age alone.

• Qulipta is the first and only oral CGRP receptor antagonist approved for *both* episodic and chronic migraine prevention.
• It can be taken with or without food, at any time of day.
• Patients should be educated on the importance of consistent daily dosing for optimal efficacy.
• Counsel patients on potential gastrointestinal side effects like constipation and nausea, and strategies to manage them (e.g., increased fiber, fluids).
• Careful review of concomitant medications is crucial due to significant interactions with strong CYP3A4 inducers and inhibitors.

• Beta-blockers (e.g., propranolol, metoprolol)
• Anticonvulsants (e.g., topiramate, valproate)
• Antidepressants (e.g., amitriptyline, venlafaxine)
• OnabotulinumtoxinA (Botox) for chronic migraine
• Non-pharmacological approaches (e.g., biofeedback, cognitive behavioral therapy, acupuncture)

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 information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.