What is Onsolis?Onsolis is used to treat breakthrough pain in adults with cancer who regularly use another opioid (narcotic) pain medicine, such as morphine, around-the-clock for constant cancer pain. Onsolis is started only after you have been taking another opioid pain medicine and your body is used to it (opioid tolerant). Do not use Onsolis if you are not opioid tolerant.
Onsolis is a federally controlled substance because it has abuse potential.
What is the most important information I should know about Onsolis?Onsolis can cause life-threatening breathing problems that can lead to death if you are not opioid tolerant, if you do not use Onsolis exactly as prescribed by your doctor, or if a child takes Onsolis by accident.
Keep Onsolis in a safe place away from children. Accidental use by a child is a medical emergency and can result in death. Get emergency help right away. If possible, try to remove Onsolis from the child's mouth.
Onsolis is available only through a restricted distribution program called the FOCUS Program. Onsolis will be delivered directly to you from a specialty pharmacy after you enroll.
Call your doctor or get emergency medical help right away if you have breathing problems, drowsiness, faintness, dizziness, confusion, or any other unusual symptoms. These can be signs of an overdose. Your dose of Onsolis may be too high for you. These symptoms may lead to serious problems or death if not treated right away. Do not take another dose of Onsolis.
Who should not take Onsolis?Do not use Onsolis if you are not already taking another opioid pain medicine around-the-clock for your constant pain.
Do not use Onsolis if you only have pain for a short time, from surgery, headache, migraine, or dental work.
Do not use Onsolis if you are allergic to any of its ingredients.
What should I tell my doctor before I take the first dose of Onsolis?Tell your doctor about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with Onsolis. Also, talk to your doctor about your complete medical history, especially if you have brain problems/head injury, breathing problems (asthma, wheezing, shortness of breath), heart problems/slow heart rate, a history of or a present condition of alcoholism or drug abuse/addiction, kidney or liver problems, low blood pressure, mental health problems, or seizures.
What is the usual dosage?The information below is based on the dosage guidelines your doctor uses. Depending on your condition and medical history, your doctor may prescribe a different regimen. Do not change the dosage or stop taking your medication without your doctor's approval.
Adults: The starting dose is 200 micrograms (mcg). Afterwards, your doctor will change the dose as necessary for control of your pain.
How should I take Onsolis?Take Onsolis exactly as prescribed by your doctor. Do not take Onsolis more often than prescribed.
Onsolis should be used only one time for each episode of breakthrough cancer pain. Separate doses by at least 2 hours.
Do not use Onsolis for more than four episodes of breakthrough cancer pain in 1 day. If you have more than four episodes each day, talk to your doctor. The dose of the opioid pain medicine for your constant pain may need to be changed. Also, if the dose of Onsolis does not relieve your breakthrough cancer pain, talk to your doctor. The dose of Onsolis may need to be changed.
Open the Onsolis package immediately prior to use. Wet the inside of your cheek with your tongue or rinse your mouth with water to wet the area for placement. Place the Onsolis film inside your mouth with the pink side against the inside of your moistened cheek. Press and hold in place for 5 seconds. Leave the film in place until it dissolves. You may drink liquids after 5 minutes. Do not eat food until the film dissolves.
If your doctor tells you to use more than one film at the same time, do not put the films on top of each other. Place them on either side of your mouth.
What should I avoid while taking Onsolis?Avoid driving, operating machinery, or doing other dangerous activities until you know how Onsolis affects you. Onsolis can make you sleepy. Ask your doctor when it is okay to do these activities.
Avoid drinking alcohol while using Onsolis. It can increase your chance of having dangerous side effects.
What are possible food and drug interactions associated with Onsolis?If Onsolis is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Onsolis with the following: antibiotics or antifungals (such as clarithromycin, erythromycin, fluconazole, itraconazole, ketoconazole, rifabutin, rifampin, telithromycin), antidepressants (such as nefazodone and monoamine oxidase inhibitors), antihistamines, anxiety medicines, aprepitant, carbamazepine, cimetidine, diltiazem, grapefruit juice, HIV medications (such as efavirenz, indinavir, nelfinavir, nevirapine, ritonavir, saquinavir), modafinil, other pain medicines, oxcarbazepine, phenobarbital, phenytoin, pioglitazone, sleeping pills, steroids, St. John's wort, tranquilizers such as barbiturates, troglitazone, or verapamil.
What are the possible side effects of Onsolis?Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking this drug.
Side effects may include: constipation, dehydration, dizziness, nausea, shortness of breath, sleepiness, vomiting
Can I receive Onsolis if I am pregnant or breastfeeding?Onsolis may harm your unborn baby if taken during pregnancy. Onsolis passes through your breast milk and can cause serious harm to your baby. Do not use Onsolis while breastfeeding. Tell your doctor immediately if you are pregnant, plan to become pregnant, or are breastfeeding.
What should I do if I miss a dose of Onsolis?Onsolis is not a regularly scheduled medicine. It should only be used for breakthrough cancer pain. Remember to continue taking your regular around-the-clock opioid medicine, and take Onsolis only when you experience an episode of breakthrough pain and exactly as prescribed.
How should I store Onsolis?Store at room temperature. Do not freeze and protect from moisture.
To dispose of films that are not needed, remove the film from its package, drop into the toilet, and flush.
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