Caspofungin

Caspofungin is injected into a vein through an IV. A healthcare provider will give you this injection.

Caspofungin must be given slowly, and the IV infusion can take at least 1 hour to complete.

You may be shown how to use an IV at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

Caspofungin is usually given for at least 14 days. You may need to receive this medicine until it has been at least 7 days after your symptoms disappear, or 14 days after lab tests show that the infection has cleared.

Use caspofungin for the full prescribed length of time. Your symptoms may improve before the infection is completely treated.

You may be given other medications to treat your infection. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.

Caspofungin is a powder medicine that must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medication.

Use only the liquid diluent that you have been given to mix with caspofungin. Liquids that contain dextrose or glucose should never be mixed with caspofungin.

Prepare your dose only when you are ready to give an injection. Do not use the medicine if it looks cloudy or has particles in it. Call your pharmacist for new medicine.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Store caspofungin powder in a refrigerator. Do not freeze. You may take the powder out of the refrigerator and allow it to reach room temperature before mixing your medicine.

After mixing caspofungin with a diluent, you may store the mixture for up to 24 hours at room temperature, or up to 48 hours in a refrigerator.

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

Since caspofungin is usually given by a healthcare professional, it is not likely that you will miss a dose. If you are using the injections at home and you miss a dose, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• CASPOFUNGIN/CYCLOSPORINE
• CASPOFUNGIN/TACROLIMUS

This is not a complete list of Caspofungindrug interactions. Ask your doctor or pharmacist for more information.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Tell your doctor at once if you have:

• pain, swelling, or vein irritation around the IV needle;

• fever, chills, body aches, flu symptoms;

• swelling in your hands or feet;

• weakness, muscle cramps, pounding or uneven heart beats;

• low potassium--confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling; or

• liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects include:

• diarrhea;

• abnormal liver function tests;

• skin rash; or

• dizziness, feeling light-headed.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with caspofungin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

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.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• 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.

This information should not be used to decide whether or not to take caspofungin or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to caspofungin. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Store intact vials at 2°C to 8°C (36°F to 46°F). Reconstituted solution may be stored at ≤25°C (≤77°F) for up to 1 hour prior to preparation of infusion solution. Solutions diluted in NS, 1/2NS, 1/4NS, or LR for infusion should be used within 24 hours when stored at ≤25°C (≤77°F) or within 48 hours when stored at 2°C to 8°C (36°F to 46°F).

Applies to caspofungin: intravenous powder for solution

Along with its needed effects, caspofungin 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 or nurse immediately if any of the following side effects occur while taking caspofungin:

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• blue lips, fingernails, or skin
• blurred vision
• changes in skin color
• chest pain
• confusion
• convulsions (seizures)
• cough
• cracked lips
• decreased urine
• diarrhea
• difficult or troubled breathing
• difficulty with swallowing
• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
• dry mouth
• fever
• headache
• increased thirst
• irregular heartbeat
• irregular, fast or slow, or shallow breathing
• loss of appetite
• mood changes
• muscle pain or cramps
• nausea or vomiting
• nervousness
• numbness or tingling in your hands, feet, or lips
• pain or redness at the injection site
• pain, tenderness, or swelling of the foot or leg
• pale skin
• pounding in the ears
• rapid weight gain
• shortness of breath
• slow or fast heartbeat
• sneezing
• sore throat
• sores, ulcers, or white spots on the lips, tongue, or inside the mouth
• sweating
• tightness in the chest
• troubled breathing with exertion
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight gain or loss
• wheezing

• Bloody urine
• decreased frequency or amount of urine
• increased blood pressure
• lower back or side pain
• weight gain
• yellow eyes or skin

• Abdominal or stomach pain or tenderness
• black, tarry stools
• bladder pain
• bleeding gums
• blood in the urine or stools
• bloody nose
• chest pain or discomfort
• clay-colored stools
• cloudy urine
• constipation
• dark urine
• decreased appetite
• depression
• drowsiness
• fever with or without chills
• flushed, dry skin
• frequent urge to urinate
• fruit-like breath odor
• general feeling of tiredness or weakness
• incoherent speech
• increased hunger
• increased urination
• indigestion
• itching
• light-colored stools
• metallic taste
• muscle spasms (tetany) or twitching seizures
• muscle weakness
• no blood pressure or pulse
• noisy, rattling breathing pain or discomfort in arms, jaw, back, or neck
• pains in stomach, side, or abdomen, possibly radiating to the back
• pinpoint red spots on skin
• rapid, shallow breathing
• rapid weight gain
• rash
• right upper abdominal or stomach pain and fullness
• shakiness in the legs, arms, hands, or feet
• stomach pain, continuing
• stopping of heart
• trembling or shaking of hands or feet
• troubled breathing at rest
• ulcers, sores, or white spots in the mouth
• unconsciousness
• unexplained weight loss
• unpleasant breath odor
• vomiting of blood
• weakness
• weight loss

Some side effects of caspofungin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Flushing, redness of skin
• unusually warm skin

• Acid or sour stomach
• back pain
• belching
• blistering, peeling, or loosening of skin
• bumps on skin
• difficulty in moving
• dry, red, hot, or irritated skin
• fear
• flaking and falling off of skin
• full or bloated feeling
• heartburn
• hives or welts
• indigestion
• joint or muscle pain
• lack or loss of strength
• muscle pain or stiffness
• pressure in the stomach
• red skin lesions, often with a purple center
• red, irritated eyes
• redness of skin
• sleepiness or unusual drowsiness
• sleeplessness
• small red or purple spots on skin
• stomach discomfort, upset, or pain
• swelling of abdominal or stomach area
• trouble sleeping
• unable to sleep

Adults:
Mild hepatic dysfunction (Child-Pugh score 5 to 6): No adjustment recommended.

Moderate hepatic dysfunction (Child-Pugh score 7 to 9):
Loading dose (where recommended): 70 mg IV on day 1
Maintenance dose: 35 mg IV once a day

Severe hepatic dysfunction (Child-Pugh score greater than 9): Data not available

Pediatrics: Data not available

Caspofungin is not removed by hemodialysis, thus supplementary dosing is not required following hemodialysis.