Nausap 150 mg Solution

NAUSAP 150 IV contains the active substance fosaprepitant which is converted to aprepitant in your body. NAUSAP 150 IV belongs to a group of medicines called “neurokinin 1 (NK 1) receptor antagonists”. NAUSAP 150 IV is used in combination with other medicines to prevent and control nausea (feeling sick) and vomiting caused by your chemotherapy (cancer treatment).

NAUSAP 150 IV should not be administered to you:

• if you are hypersensitive (allergic) to fosaprepitant, aprepitant or to polysorbate 80 or any of the other ingredients of NAUSAP 150 IV (listed in section 6)
• with medicines containing pimozide (used to treat psychiatric illnesses), terfenadine and astemizole (used for hay fever and other allergic conditions), cisapride (used for treating digestive problems). Tell your doctor if you are taking these medicines since your treatment must be modified before you start using NAUSAP 150 IV.
• if you are pregnant or breastfeeding. Do not give NAUSAP 150 IV to children, because NAUSAP 150 IV has not been adequately studied in children.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using NAUSAP 150 IV:

• if you have or have had any past or present medical problems
• if you have liver disease. Before treatment with this medicine, tell your doctor if you have liver disease because your liver is important in breaking down the medicine in your body. Your doctor may therefore have to monitor the condition of your liver.
• If you have any allergies
• If you are taking or plan to take any medicine, even those you can get without a prescription or herbal products

Tell your doctor or nurse if you experience local irritation at the injection site.

Children and adolescents

NAUSAP 150 IV has not been adequately studied in children. Therefore, NAUSAP 150 IV should not be given to children.

Use in elderly

No dosage adjustment is necessary for elderly patients.

Do not share medicines prescribed for you with any other person. You will not be expected to give yourself NAUSAP 150 IV. It will be given to you by a person who is qualified to do so. In adults, the recommended dose of NAUSAP 150 IV is 150 mg fosaprepitant on Day 1 (day of chemotherapy). The powder is reconstituted and diluted before use. The solution for infusion is given to you by a healthcare professional, such as a doctor or nurse, via an intravenous infusion (a drip) over 20 to 30 minutes approximately 30 minutes before your start of chemotherapy treatment. Your doctor will ask you to take other medicines including a corticosteroid (such as dexamethasone) and a “5-HT 3 antagonist” (such as ondansetron) for preventing nausea and vomiting. Check with your doctor or pharmacist if you are not sure.

If you receive more NAUSAP 150 IV than you should

Since a health care provider will administer NAUSAP 150 IV, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

If you miss a dose of NAUSAP 150 IV

If you are concerned that you may have missed a dose of NAUSAP 150 IV, talk to your doctor, pharmacist or nurse straight away. Since a health care provider will administer NAUSAP 150 IV, it is unlikely that the dose will be missed.

NAUSAP 150 IV can have side effects. Not all side effects reported for NAUSAP 150 IV are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving NAUSAP 150 IV, please consult your health care provider for advice. If any of the following happens, stop using NAUSAP 150 IV and tell your doctor immediately:

• Hives (raised itchy/bumps on the skin), rash, itching, redness of the face/skin, swelling of the face, throat, tongue and lips, difficulty breathing or swallowing, or a serious decrease of blood pressure (frequency not known, cannot be estimated from the available data). These are signs of a serious allergic reaction.
• Infusion site reactions (ISR) at or near the infusion site. Most severe ISR have happened with a certain type of chemotherapy medicine that can burn or blister your skin (vesicant) with side effects, including pain, swelling and redness. Death of skin tissue (necrosis) has happened in some people getting this type of chemotherapy medicine. These are all very serious side effects. You need immediate/urgent medical attention.

Other side effects that have been reported are listed below. Tell your doctor or nurse if you notice any of the following:

Frequent side effects:

• constipation, indigestion
• headache
• fatigue
• loss of appetite
• hiccups
• increased amount of a liver enzyme (ALT) in your blood.

Less frequent side effects:

• bacterial infection, fungal infection
• fever with increased risk of infection, lowering of red blood cells
• excessive thirst
• anxiousness, disorientation, euphoria (feeling of extreme happiness)
• dizziness, sleepiness, difficulty thinking, lack of energy, taste disturbance
• eye discharge and itching

NAUSAP 150 IV should be stored refrigerated at 2 to 8 °C. Since NAUSAP 150 IV does not contain a preservative it is advisable that the product be used immediately after reconstitution. The reconstituted and diluted solution is stable for 24 hours at or below 25°C. Store all medicines out of reach of children.