Patient Medication Information: uses, side effects, how to take - Fosaprepitant
ABOUT THIS MEDICATION
What the medication is used for:
FOSAPREPITANT, in combination with 5-HT3 antagonists and dexamethasone, is indicated for the prevention of nausea and vomiting associated with your cancer chemotherapy treatment.
What it does:
FOSAPREPITANT is a member of a class of medicines called neurokinin 1 (NK1) receptor antagonists. Fosaprepitant when administered intravenously is rapidly converted to aprepitant. Aprepitant works by blocking neurokinin, a substance in the brain that causes nausea and vomiting.
When it should not be used:
Do not take FOSAPREPITANT if you are allergic to fosaprepitant dimeglumine, aprepitant or any of the other ingredients of FOSAPREPITANT.
Do not take FOSAPREPITANT with pimozide, terfenadine, astemizole, or cisapride. Taking FOSAPREPITANT with these medications could result in serious or life-threatening problems.
What the medicinal ingredient is:
Fosaprepitant dimeglumine
What the important non-medicinal ingredients are:
edetate disodium, lactose anhydrous, polysorbate 80 and sodium hydroxide and/or hydrochloric acid (for pH adjustment).
What dosage forms it comes in:
Powder for injection. Each vial contains 150 mg of fosaprepitant.
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
Drug interactions may occur with:
Possible serious side effects:
|
BEFORE you use FOSAPREPITANT talk to your physician or pharmacist if you:
- have any past or present medical problems
- have liver problems
- have any allergies
drive a car or operate machinery
are pregnant or plan to become pregnant
- are breast-feeding or plan to breast-feed
Use in children
FOSAPREPITANT should not be given to children under 18 years of age.
Use in the elderly
No dosage adjustment is necessary.
INTERACTIONS WITH THIS MEDICATION
Tell your physician about all medicines that you are taking or plan to take, even those you can get without a prescription or herbal products.
Your physician may check that your medicines are working properly together if you are taking other medicines such as:
- anti-anxiety drugs (such as alprazolam, midazolam)
- birth control medicines (which may not work as well)
- ketoconazole (an antifungal)
- rifampin (an antibiotic)
- paroxetine (a medicine used to treat a certain type of depression)
- diltiazem (a medicine used to treat high blood
- pressure)
- dexamethasone, methylprednisolone (steroid medicines used for a variety of conditions)
- warfarin (a blood thinner)
- tolbutamide (a medicine used to treat diabetes)
- phenytoin (a medicine used to treat seizures)
- some chemotherapy medications such as ifosfamide
PROPER USE OF THIS MEDICATION
FOSAPREPITANT may be taken with or without food.
Usual dose:
FOSAPREPITANT 150 mg given on Day 1 only.
- Day of chemotherapy: FOSAPREPITANT 150 mg will be given to you intravenously approximately 30 minutes before you start your chemotherapy treatment.
Overdose:
| In case of a drug overdose, contact a health care practitioner, hospital emergency department or Regional Poison Control Centre, immediately. |
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all prescription drugs, FOSAPREPITANT may cause side effects. Just because side effects have occurred in other patients does not mean you will get them. If you experience any side effects that bother you, please contact your doctor or pharmacist.
Side effects include:
- low white blood cell counts
- diarrhea
- stomach pain
- constipation
- upset stomach
- nausea
- vomiting
- fatigue
- dizziness
- weakness
- loss of appetite
- joint pain
- taste disturbance
- headache
- urinary tract infection
- dehydration
- pain and/or tingling in the limbs
- anxiety
- nose bleeds
- hiccups
- low red blood cell counts
- chest pain
- shortness of breath
sores in the mouth
Infusion site reactions (ISR) at or near the infusion site have happened with fosaprepitant.
Most severe ISR have happened with a certain type of chemotherapy medicine that can burn or blister your skin with side effects, including pain, swelling, redness and hardening at the site of infusion. Death of skin tissue has happened in some people getting this type of chemotherapy medicine. Tell your healthcare provider right away if you get any infusion site side effects.
Side effects seen with fosaprepitant capsules may also be seen with fosaprepitant.
- upset stomach and pain
- trouble sleeping (insomnia)
- hair loss (alopecia)
- fever
- ringing in the ears
- slow heart rate
- ulcers
- disorientation
Ask your physician or pharmacist for more information. Both have a more complete list of side effects. Tell your physician or pharmacist promptly about these or any other unusual symptoms.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||
| Symptoms/Effects | Talk with your physician or pharmacist | Stop taking drug and call your physician or pharmacist |
| Only if severe | In all cases | |
| Uncommon | ||
| Allergic reactions, which may be sudden and/or serious, and may include: swelling (face, eyes, lips, tongue, throat and skin), rash, itching, redness of the face/skin, difficulty in breathing/ swallowing , and serious decrease of blood pressure. | ||
| √ | ||
| Uncommon | Stevens- Johnson syndrome/ toxic epidermal necrolysis (severe skin reactions, blistering) | √ | ||
| Uncommon | Urticaria (severe rash, itching, swelling of the hands and feet) | √ |
This is not a complete list of side effects. For any unexpected effects while taking FOSAPREPITANT, contact your physician or pharmacist.
HOW TO STORE IT
Vials: Sterile powder for intravenous use. Store at 2°C to 8°C.
Keep FOSAPREPITANT and all medicines safely away from children.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice |
MORE INFORMATION
If you want more information about FOSAPREPITANT:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp). Find the Consumer Information on manufacturer’s website http://www.apotex.ca/products, or by calling 1-800-667-4708.