AUDIENCE: Pharmacy, Oncology, Nursing
ISSUE: Anaphylaxis, anaphylactic shock and other serious hypersensitivity reactions have been reported in the postmarketing setting, some requiring hospitalization. These reactions have occurred during or soon after the infusion of rolapitant injectable emulsion. Most reactions have occurred within the first few minutes of administration. Symptoms of anaphylaxis can include wheezing or difficulty breathing; swelling of the face or throat; hives or flushing; itching; abdominal cramping, abdominal pain or vomiting; back pain or chest pain; hypotension or shock.
See the Health Care Provider Letter, available at: http://bit.ly/2mDISBr, for important prescribing information to reflect the new safety information.
BACKGROUND: Rolapitant injectable emulsion is approved to prevent delayed phase chemotherapy-induced nausea and vomiting (emesis). Rolapitant is approved in adults in combination with other drugs (antiemetic agents) that prevent nausea and vomiting associated with initial and repeat courses of vomit-inducing (emetogenic and highly emetogenic) cancer chemotherapy.
RECOMMENDATION: Healthcare professionals must be vigilant for signs of hypersensitivity or anaphylaxis in all patients receiving rolapitant injectable emulsion, both during and following its administration. It is advised that Healthcare professionals consult with patients to determine if the patient is hypersensitive to any component of the product (including soybean oil). Furthermore, as cross reactions to other allergens is possible, patients with known allergies to legumes or other related allergens should be monitored closely. Patients with a potential hypersensitivity should not be administered rolapitant injectable emulsion.
Appropriate treatment should be available for immediate use in the event of an anaphylactic reaction during treatment with rolapitant injectable emulsion.
If anaphylaxis or any other serious hypersensitivity/infusion reaction occurs,
- administration of rolapitant injectable emulsion should be stopped immediately.
- appropriate medical management (including epinephrine and or antihistamines) should be initiated, and
- Rolapitant injectable emulsion should be permanently discontinued.
For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.
Why is this medication prescribed?
Rolapitant is used along with other medications to prevent nausea and vomiting that may occur several days after receiving certain chemotherapy medications. Rolapitant is in a class of medications called antiemetics. It works by blocking the action of neurokinin and substance P, natural substances in the brain that cause nausea and vomiting.
How should this medicine be used?
Rolapitant comes as a tablet to take by mouth. It is usually taken as a single dose about 1 to 2 hours before the start of chemotherapy. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take rolapitant exactly as directed.
Do not take rolapitant more than once every 14 days.
Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.
Other uses for this medicine
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Before taking rolapitant,
- tell your doctor and pharmacist if you are allergic to rolapitant, any other medications, or any of the ingredients in rolapitant tablets. Ask your pharmacist for a list of the ingredients.
- tell your doctor if you are taking thioridazine. Your doctor will probably tell you not to take thioridazine if you are taking this medication.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: digoxin (Lanoxin), irinotecan (Camptosar), methotrexate (Otrexup, Rasuvo, Trexall), pimozide (Orap), rifampin (Rifadin, Rimactane, in Rifamate, in Rifater), rosuvastatin (Crestor), and topotecan (Hycamtin). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with rolapitant, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
- tell your doctor if you have or have ever had liver disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking rolapitant, call your doctor.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do if I forget a dose?
Rolapitant should only be taken before chemotherapy as instructed by your doctor. It should not be taken on a regularly scheduled basis.
What side effects can this medication cause?
Rolapitant may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- stomach pain
- decreased appetite
Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:
- mouth sores
Rolapitant may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).
What should I know about storage and disposal of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).
Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.
It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org
In case of emergency/overdose
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
What other information should I know?
Keep all appointments with your doctor.
Do not let anyone else take your medication.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.