Cancidas

Caspofungin is an antifungal medicine. It is used to help the body overcome serious fungus infections, including Candida and Aspergillosis infections. It is also used to treat serious fungus infections when other medicines (e.g., amphotericin B, itraconazole) have failed.

This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:

• Powder for Solution

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:

1. 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.

2. Pediatric Population:
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of caspofungin in children. Safety and efficacy have not been established in children below 3 months of age.

3. Geriatric Population:
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of caspofungin in the elderly.

4. Pregnancy:
Category C: Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

5. Breastfeeding:
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.

6. Drug Interactions:
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
• 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

7. 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.

8. 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 (e.g. hepatitis, liver failure)—Higher blood levels of caspofungin may result, increasing the chance of side effects.

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

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 has worked properly. Blood tests may be needed to check for unwanted effects.

Check with your doctor right away if you or your child have any symptoms of liver problems including dark-colored urine or pale stools, nausea, vomiting, loss of appetite, pain in your upper stomach, or yellowing of your skin or the whites of your eyes.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis 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.

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.

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
• 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

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

• 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 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 skin
• Unusually warm skin

Incidence not known

• 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

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.