Nebupent

You should not use pentamidine if you are allergic to it.

To make sure pentamidine is safe for you, tell your doctor if you have:

• high or low blood pressure;

• a heart rhythm disorder;

• diabetes, or low blood sugar (hypoglycemia);

• a pancreas disorder;

• a severe skin rash called Stevens-Johnson syndrome;

• anemia (low red blood cells);

• low white blood cells or low platelets in your blood;

• low levels of calcium or high levels of potassium in your blood;

• liver or kidney disease; or

• a history of smoking or asthma.

FDA pregnancy category C. It is not known whether pentamidine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether pentamidine passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Inhaled pentamidine should not be given to a child without the advice of a doctor.

Pentamidine is given either as an injection, or as in inhaled medicine using a nebulizer. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Pentamidine is a powder medicine that must be mixed with a liquid (diluent) before using it as an injection or with a nebulizer. If you are using this medicine at home, be sure you understand how to properly mix and store the medicine. Use only the diluent provided with your medication.

To use pentamidine as an injection:

• Pentamidine is injected into a muscle, or into a vein through an IV. You may be shown how to use an IV at home. Do not self-inject this medicine if you do not understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

• Do not use pentamidine if it has changed colors or has particles in it. Call your pharmacist for new medication.

• Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when pentamidine is injected.

• Use a disposable needle only once, then throw away in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

To use pentamidine with a nebulizer:

• After mixing your medicine with the diluent, pour all of the mixture into the chamber of the nebulizer. Attach the mouthpiece or face mask, then attach the drug chamber to the compressor.

• Do not mix any other medicines in the nebulizer with pentamidine.

• Sit upright in a comfortable position. Place the mouthpiece into your mouth or put on the face mask, covering your nose and mouth. Turn on the compressor.

• Breathe in slowly and evenly until no more mist is formed by the nebulizer and the drug chamber is empty.

• Clean the nebulizer after each use. Follow the cleaning directions that came with your nebulizer.

If you are diabetic, check your blood sugar carefully while you are receiving pentamidine. This medicine can raise or lower your blood sugar.

While using pentamidine, you may need frequent blood tests. Your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG).

Store unmixed medicine at room temperature away from moisture, heat, and light.

Mixed medicine must be used within a certain number of hours, depending on the diluent. Carefully follow the mixing and storage instructions provided with your medicine. Ask your pharmacist if you have questions.

Pentamidine contains no preservative. Throw away any unused medicine.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

In the U.S.

• Nebupent

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antiprotozoal

Pentamidine is used to try to prevent Pneumocystis carinii pneumonia (PCP), a very serious type of pneumonia. This type of pneumonia occurs commonly in patients whose immune systems are not working normally, such as patients with acquired immune deficiency syndrome (AIDS). Inhaled pentamidine does not prevent illness in parts of the body outside the lungs. This medicine may also be used for other conditions as determined by your doctor.

Pentamidine is available only with your doctor's prescription.

On rare occasions, pneumocystis infections have occurred in parts of the body outside the lungs in patients receiving pentamidine inhalation therapy. You should discuss this possible problem with your doctor.

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:

• Burning pain, dryness, or sensation of lump in throat
• chest pain or congestion
• coughing
• difficulty in breathing
• difficulty in swallowing
• skin rash
• wheezing

• Nausea and vomiting
• pain in upper abdomen, possibly radiating to the back
• pain in side of chest (severe)
• shortness of breath (sudden and severe)

• Anxiety
• chills
• cold sweats
• cool, pale skin
• decreased urination
• headache
• increased hunger
• loss of appetite
• nausea and vomiting
• nervousness
• shakiness
• stomach pain
• unusual tiredness

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.

• It is used to prevent Pneumocystis jirovecii pneumonia.
• It may be given to you for other reasons. Talk with the doctor.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• To gain the most benefit, do not miss doses.
• Keep taking Nebupent as you have been told by your doctor or other health care provider, even if you feel well.
• For breathing in only as a liquid (solution) by a special machine (nebulizer) into the lungs.
• Your doctor may teach you how to give this medicine.
• Follow how to take Nebupent as you have been told by your doctor. Do not use more than you were told to use.
• This medicine needs to be mixed before use. Follow how to mix as you were told by the doctor.
• Do not mix other drugs in nebulizer.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

The potential for development of acute PJP still exists in patients receiving NebuPent prophylaxis. Therefore, any patient with symptoms suggestive of the presence of a pulmonary infection, including but not limited to dyspnea, fever or cough, should receive a thorough medical evaluation and appropriate diagnostic tests for possible acute PJP as well as for other opportunistic and nonopportunistic pathogens. The use of NebuPent may alter the clinical and radiographic features of PJP and could result in an atypical presentation, including but not limited to mild disease or focal ­infection.

Prior to initiating NebuPent prophylaxis, symptomatic patients should be evaluated appropriately to exclude the presence of PJP. The recommended dose of NebuPent for the prevention of PJP is insufficient to treat acute PJP.