Overview: Orzeyful is used to treat narcolepsy. It works by binding to receptors in the brain that affect wakefulness. Common side effects may include trouble sleeping, having an urgent or frequent need to pee, or making too much saliva. Tell your health care provider right away if you have muscle pain, weakness, or tenderness, or if you have dark-colored pee (urine), as these could be signs of a serious side effect. Orzeyful interacts with many medicines, so tell your health care provider about all medicines and supplements you use before taking it.
Uses
What is Orzeyful used for?
Orzeyful (oveporexton) is commonly used to treat certain people with narcolepsy, which is a condition that affects your ability to wake and sleep.
Living With Narcolepsy Type 1: How Orzeyful Can Help
Orzeyful may also be used for other conditions as determined by your health care provider.
How does Orzeyful work (mechanism of action)?
Orexins are naturally occurring substances in the brain that promote wakefulness and regulate muscle tone. People with narcolepsy may have less orexin signaling in the brain. Orzeyful works by binding to and acting on orexin receptors, which may make it easier to stay awake.
How is Orzeyful supplied (dosage forms)?
Brands and other names
- Orzeyful
Dosage forms and strengths
- 0.5 mg oral tablets
- 1 mg oral tablets
- 2 mg oral tablets
How should I store Orzeyful?
Orzeyful should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place.
Side Effects
What are the most common side effects of Orzeyful?
The most common side effects of Orzeyful are listed below. Tell your health care provider if you have any of these side effects that bother you.
- Trouble sleeping (see below)
- Frequent or urgent need to pee (see below)
- Making too much saliva
There may be other side effects of Orzeyful that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What are the serious side effects of Orzeyful?
While less common, the most serious side effects of Orzeyful are described below, along with what to do if they happen.
Severe Allergic Reactions. Orzeyful may cause allergic reactions, which can be serious. Stop taking Orzeyful and get help right away if you have any of the following symptoms of a serious allergic reaction.
- Breathing problems or wheezing
- Racing heart
- Fever or general ill feeling
- Swollen lymph nodes
- Swelling of the face, lips, mouth, tongue, or throat
- Trouble swallowing or throat tightness
- Itching or skin rash
- Bumps on the skin called hives that can be red, pink, white, or brown depending on your skin tone
- Nausea or vomiting
- Dizziness, feeling lightheaded, or fainting
- Stomach cramps
- Joint pain
Trouble Sleeping. Orzeyful can cause trouble sleeping (insomnia), which may include trouble falling asleep or staying asleep. Tell your health care provider if you have trouble sleeping for more than 7 days or if you have a hard time doing your normal daily activities while taking Orzeyful.
Frequent or Urgent Need to Pee. Orzeyful can make you feel like you need to pee (urinate) many times throughout the day. It can also make you feel a sudden, urgent need to pee. If you already have peeing problems, it may make these problems worse. Tell your health care provider if you need to pee more often or more urgently than usual.
Muscle Problems. Orzeyful can increase the risk of high creatine phosphokinase (CPK) levels in your blood. High CPK levels can sometimes be a sign of muscle problems called myopathy. Tell your health care provider right away if you have any of the following symptoms, especially if you are doing a lot of physical activity or take certain medicines.
- Unexplained muscle pain, weakness, or tenderness
- Dark-colored urine (pee)
- Low energy levels or feeling easily tired, especially with activity
- Fever
- Muscle cramps
- Stomach pain
- Nausea or vomiting
Risk of Misuse and Addiction. Orzeyful has the potential to be misused or abused. Misuse means taking a medicine in a way other than how it was prescribed. Take Orzeyful exactly as prescribed. Tell your health care provider if you feel that Orzeyful is not working.
Warnings & Precautions
Who should not use Orzeyful?
Allergies to Ingredients. People who are allergic to any of the following should not take Orzeyful.
- Orzeyful
- Oveporexton
- Any of the ingredients in the specific product dispensed
Your pharmacist can tell you all of the ingredients in Orzeyful.
Drug Interactions. Orzeyful should not be taken while you are using certain other medicines. Before taking Orzeyful, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.
What should I know about Orzeyful before using it?
Do not take Orzeyful unless it has been prescribed to you by a health care provider. Take it as prescribed.
Do not share Orzeyful with other people, even if they have the same condition as you. It may harm them.
Keep Orzeyful out of the reach of children.
Do not chew, cut, or crush Orzeyful. Swallow the tablets whole with water.
What should I tell my health care provider before using Orzeyful?
Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Orzeyful is right for you.
In particular, make sure that you discuss any of the following.
Current and Past Health Conditions. Tell your health care provider if you have or have had any of the following.
- Problems peeing or with your bladder, such as overactive bladder (OAB)
- Liver problems
- Kidney problems
- Misuse of prescription or street drugs, such as stimulants like amphetamine, cocaine, or methylphenidate
Pregnancy. It is not known if or how Orzeyful could affect pregnancy or harm a fetus. Tell your health care provider if you are pregnant or plan to become pregnant. If you become pregnant while taking Orzeyful, you can sign up for the drugmaker’s pregnancy registry by calling 877-371-0309. This registry collects safety information about the use of Orzeyful during pregnancy.
Breastfeeding. It is not known if Orzeyful passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should take Orzeyful while breastfeeding.
How can I get more information about Orzeyful?
For more information about Orzeyful, you can visit the drugmaker’s website at www.orzeyful.com or call them at 877-825-3327.
Interactions
Does Orzeyful interact with foods or drinks?
Ask your health care provider if you should avoid eating grapefruit or drinking grapefruit juice while taking Orzeyful. The combination may increase blood levels of the medicine, possibly raising the risk of side effects.
It is unknown if drinking alcohol will affect Orzeyful, but alcohol may affect sleep. Talk with your health care provider about your alcohol intake.
Does Orzeyful interact with other medicines (drug interactions)?
Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.
In particular, make sure that you discuss if you are using any of the following before taking Orzeyful.
- Fluconazole (Diflucan), itraconazole (Sporanox, Tolsura), ketoconazole, posaconazole (Noxafil), or voriconazole (Vfend), which is a medicine used for fungal infections
- Phenytoin (Dilantin, Phenytek, and others), which is a medicine to control seizures
- Carbamazepine (Carbatrol, Tegretol, and others), which is a medicine commonly used to treat seizures or nerve pain
- Erythromycin (Ery-Tab and others) or ciprofloxacin (Cipro), which is a medicine used for bacterial infections
- Diltiazem (Cardizem CD and others) or verapamil (Verelan, Verelan PM), which is a medicine used for high blood pressure or other conditions
- Rifampin (Rifadin), which is a medicine commonly used to treat an infection called tuberculosis
- Phenobarbital or primidone, which is a medicine that may be used to treat seizures
- St. John’s wort, which is a supplement that may be used for depression
Many other medicines may alter the blood levels of Orzeyful, and vice versa. Tell your health care provider about all medicines that you take or have recently taken.
This may not be a complete list of medicines that can interact with Orzeyful. Always check with your health care provider.
Overdose/Missed Dose
What should I do if I accidentally use too much Orzeyful?
If you or someone else has used too much Orzeyful, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.
What should I do if I miss a dose of Orzeyful?
If you miss a dose, skip the missed dose and only take the next dose at the next scheduled time. Do not take double or extra doses.
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