"The cystic fibrosis (CF) drug Orkambi (Vertex Pharmaceuticals) has received a green light from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP).
Orkambi is a fixed-dose oral combination "...
Nebupent Consumer (continued)
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor or respiratory therapist immediately if any of these unlikely but serious side effects occur: chest tightness, breathing problems.
Though very unlikely, inhaled pentamidine might be absorbed into your body. Tell your doctor immediately if any of these rare but serious side effects occur: abdominal pain, easy bruising/bleeding, fast/irregular heartbeat, mental/mood changes (such as confusion, hallucinations), unusual decrease in the amount of urine, signs of anemia (such as severe tiredness, bluish skin/nails), signs of low blood pressure (such as severe dizziness, pale skin, fainting), signs of low blood sugar (such as sudden sweating, shaking, fast heartbeat, hunger), signs of high blood sugar (such as unusual increase in thirst or urination), signs of infection (such as fever, chills, persistent sore throat).
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the Nebupent (pentamidine isethionate) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor, respiratory therapist, or pharmacist your medical history, especially of: bleeding/blood disorders, breathing problems (such as asthma), diabetes, kidney disease, liver problems, smoking.
This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
It is unknown if this drug passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.
Additional Nebupent Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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