Description
Danicopan is used together with other medicines (eg, ravulizumab or eculizumab) to treat extravascular hemolysis (breakdown of red blood cells that takes place outside of the blood vessels) in patients with a type of blood disease called paroxysmal nocturnal hemoglobinuria (PNH).
This medicine is available only under a restricted distribution program called Voydeya™ REMS (Risk Evaluation and Mitigation Strategy) Program.
This product is available in the following dosage forms:
- Tablet
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of danicopan in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of danicopan in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Colchicine
- Cyclosporine
- Digoxin
- Everolimus
- Irinotecan
- Methotrexate
- Ozanimod
- Rosuvastatin
- Simvastatin
- Sirolimus
- Sofosbuvir
- Sulfasalazine
- Sunitinib
- Tacrolimus
- Talazoparib
- Tenofovir Alafenamide
- Teriflunomide
- Tolvaptan
- Topotecan
- Ubrogepant
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Bacterial infections (eg, pneumonia, meningitis, or flu-like infection), unresolved and serious—Should not be given to patients with these conditions.
- Infection or
- Weakened immune system—Use with caution. This medicine may decrease your body’s ability to fight infection.
- Liver disease, severe—Use is not recommended in patients with this condition.
Proper Use
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
It is very important that you understand the requirements of the Voydeya™ REMS program, and become familiar with the Voydeya™ medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions. Ask your pharmacist for the medication guide if you do not have one.
You may take this medicine with or without food. Take it at the same time each day.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (tablet):
- For extravascular hemolysis (EVH):
- Adults—At first, 150 milligrams (mg) 3 times a day. Your doctor may adjust your dose as needed.
- Children—Use and dose must be determined by your doctor.
- For extravascular hemolysis (EVH):
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
If you miss a dose, take it as soon as possible. If you miss a dose and it is within 3 hours of your next scheduled dose, skip the missed dose and take your next dose at the regular time.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
Danicopan may increase your chance of having serious infections, including Streptococcus pneumoniae or Neisseria meningitidis. Avoid people who are sick or have infections. Tell your doctor right away if you develop headaches, nausea, vomiting, fever, a stiff neck or back, a rash, confusion, muscle aches, or if your eyes have become sensitive to light. Make sure you are up to date on pneumonia and meningitis vaccines at least 2 weeks before you receive this medicine. You may also be given antibiotic medicines to prevent infections if you are to use this medicine right away. If you have already received the vaccine in the past, your doctor will decide if you need another dose.
Ask your doctor for a patient safety card. This card will list the symptoms of encapsulated bacterial infections and what to do if you have them. Carry the card with you at all times during treatment and for 1 week after your last dose. You will need to show the card to any doctor who treats you.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.
If you stop taking this medicine, you may develop hemolysis (breakdown of red blood cells). Your doctor will monitor you for at least 2 weeks after the last dose. Be sure to keep all appointments.
This medicine may increase your cholesterol and triglycerides (fats). Talk with your doctor if you have any concerns about this.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Blurred vision
- dizziness
- headache
- nervousness
- pounding in the ears
- slow or fast heartbeat
Incidence not known
- Cough or hoarseness
- dark urine
- fever or chills
- loss of appetite
- lower back or side pain
- nausea or vomiting
- painful or difficult urination
- stomach pain, severe
- unusual tiredness or weakness
- yellow eyes or skin
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Arm or leg pain
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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