Olaparib (Oral route)
Uses of This Medicine:
Olaparib is used to treat advanced ovarian cancer in patients who have received three or more cancer medicines. It is only used if the cancer cells have the germline BRCA mutations. Your doctor will use a special test to look for these mutations. Olaparib belongs to the group of medicines called antineoplastics (cancer medicines).
This medicine is available only with your doctor's prescription.
Before Using This Medicine:
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:
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.
Appropriate studies have not been performed on the relationship of age to the effects of olaparib in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of olaparib in the elderly.
|All Trimesters||D||Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.|
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.
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.
- Eslicarbazepine Acetate
- St John's Wort
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. 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 is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Bitter Orange
- Grapefruit Juice
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:
- Bone marrow problems (eg, myelodysplastic syndrome, acute myeloid leukemia) or
- Lung disease—Use with caution. May make these conditions worse.
Proper Use of This Medicine:
Medicines used to treat cancer are very strong and can have many side effects. Before using this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
Take this medicine exactly 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. To do so may increase the chance of side effects.
This medicine usually comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.
Swallow the capsules whole. Do not crush, break, chew, open, or dissolve them. Do not take capsules if they look damaged or have a leakage. You may take this medicine with or without food.
Do not eat grapefruit or Seville oranges, or drink grapefruit juice while you are using this medicine.
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 (capsules):
- For advanced ovarian cancer:
- Adults—400 milligrams (mg) (eight 50 mg capsules) 2 times a day. Each dose should be taken 12 hours apart. Your doctor may adjust your dose as needed.
- Children—Use and dose must be determined by your doctor.
- For advanced ovarian cancer:
If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
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 While Using This Medicine:
It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 6 months after the last dose of this medicine. If you think you have become pregnant while using the medicine, tell your doctor right away.
This medicine may cause bone marrow problems, such as myelodysplastic syndrome or acute myeloid leukemia. Check with your doctor right away if you have a fever, blood in the urine or stool, chills, unusual bleeding, bruising, tiredness, or weakness, or weight loss.
Tell your doctor right away if you have a chest pain, cough, or any type of breathing problem with this medicine. These could be symptoms of a serious lung problem.
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 (eg, St. John's wort) or vitamin supplements.
Side Effects of This Medicine:
- More common
- Chest pain
- ear congestion or pain
- head congestion
- hoarseness or other voice changes
- nasal congestion
- pale skin
- runny nose
- sore throat
- troubled breathing with exertion
- unusual bleeding or bruising
- unusual tiredness or weakness
- Less common
- Lower back or side pain
- painful or difficult urination
- sores, ulcers, or white spots on lips or in the mouth
- swollen glands
- More common
- Acid or sour stomach
- back pain
- blistering, crusting, irritation, itching, or reddening of the skin
- blurred vision
- burning, numbness, tingling, or painful sensations
- cracked, dry, or scaly skin
- decreased appetite
- difficulty with moving
- dry mouth
- fear or nervousness
- flushed, dry skin
- fruit-like breath odor
- increased hunger
- increased thirst
- increased urination
- lack or loss of strength
- loss of bladder control
- muscle pain or stiffness
- pain in the joints
- stomach discomfort, upset, or pain
- swelling or inflammation of the mouth
- trouble sleeping
- unexplained weight loss
- unsteadiness or awkwardness
- weakness in the arms, hands, legs, or feet
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:
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:
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.
Last Updated: 7/4/2017