Pronunciation:

kas-poe-FUN-jin

Brand Names:

• Cancidas

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Antifungal

Pharmacologic—

Glucan Synthesis Inhibitor

Chemical—

Echinocandin

Uses of This Medicine:

Caspofungin injection is used to treat serious fungal infections, including candidemia (fungal infection in the blood), esophageal candidiasis (fungal infection of the esophagus), other candida infections, and aspergillosis (fungal infection in the lungs). It is also used to treat fungal infections assumed to be present in patients with febrile neutropenia. Caspofungin injection is given when other medicines (eg, amphotericin B, itraconazole) did not work well.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of caspofungin injection in children 3 months of age and older. Safety and efficacy have not been established in children younger than 3 months of age.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of caspofungin injection in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Cyclosporine
• Levoketoconazole
• Methotrexate
• Tacrolimus

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Carbamazepine
• Dexamethasone
• Efavirenz
• Fosphenytoin
• Nevirapine
• Phenytoin
• Rifampin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Liver disease, moderate to severe (eg, hepatitis, liver failure)—Use with caution. Effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine. It is given through a needle placed into one of your veins. The medicine must be injected slowly, so the needle will have to remain in place for about 1 hour for 7 to 14 days.

Precautions While Using This Medicine:

It is very important that your doctor check the progress of you or your child while you are taking this medicine to make sure the medicine is working properly. Blood tests may be needed to check for unwanted effects.

Check with your doctor right away if you or your child have pain or tenderness in the upper stomach, dark urine, pale stools, nausea, vomiting, loss of appetite, or yellow skin or eyes. These could be symptoms of a serious liver problem.

This medicine may cause a serious type of allergic reaction, called anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving this medicine.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or a skin rash, sores or ulcers on the skin, or fever or chills with this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

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 or nurse immediately if any of the following side effects occur:

More common

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

cough

cracked lips

decreased urine

diarrhea

difficult or troubled breathing

difficulty with swallowing

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

dry mouth

fever

headache

increased thirst

irregular heartbeat

irregular, fast, slow, or shallow breathing

loss of appetite

mood changes

muscle pain or cramps

nausea

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

seizures

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

vomiting

Less common

Bloody urine

decreased frequency or amount of urine

increased blood pressure

lower back or side pain

weight gain

yellow eyes or skin

Incidence not known

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 the arms, jaw, back, or neck

pains in the stomach, side, or abdomen, possibly radiating to the back

pinpoint red spots on the skin

rapid weight gain

rash

right upper abdominal or stomach pain and fullness

shakiness in the legs, arms, hands, or feet

stomach pain, continuous

stomach pain or tenderness

stopping of heart

trembling or shaking of the 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 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:

More common

Flushing, redness of the skin

unusually warm skin

Incidence not known

Back pain

belching

blistering, peeling, or loosening of the skin

bloated or feeling of fullness

bumps on the skin

difficulty in moving

dry, red, hot, or irritated skin

fear

flaking and falling off of the skin

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 the skin

sleepiness or unusual drowsiness

small red or purple spots on the skin

stomach discomfort, upset, or pain

swelling of the abdominal or stomach area

trouble sleeping

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.