Pronunciation:

dap-toe-MYE-sin

Brand Names:

• Cubicin
• Cubicin RF
• Dapzura RT

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Antibiotic

Uses of This Medicine:

Daptomycin injection is used to treat complicated skin and skin structure infections (cSSSI). It is also used to treat infections in the bloodstream (bacteremia), including right-sided infective endocarditis.

Daptomycin belongs to the class of medicines known as antibiotics. It works by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.

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 daptomycin injection in children. However, safety and efficacy have not been established in children younger than 1 year of age.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of daptomycin injection in the elderly. However, elderly patients are more likely to have increased unwanted side effects, which may require caution in patients receiving daptomycin injection.

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.

• Atorvastatin
• Cerivastatin
• Fluvastatin
• Lovastatin
• Pitavastatin
• Pravastatin
• Rosuvastatin
• Simvastatin

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:

• Diarrhea or
• Muscle problems (eg, myopathy, rhabdomyolysis) or
• Nerve problems (eg, neuropathy)—Use with caution. May make these conditions worse.

• Hereditary fructose intolerance (HFI), known or suspected—Dapzura RT should not be used in patients with this condition. This medicine contains sorbitol, which can cause serious side effects in patients with HFI.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Lung or breathing problems (eg, pneumonia)—Use is not indicated to treat patients with this condition.

• Staphylococcus infection, persisting or relapsing—Patients with this condition should have repeated blood tests.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed into one of your veins. This medicine may be injected for 2 minutes (in adults only) or up to 60 minutes.

To help clear up your infection completely, keep using this medicine for the full time of treatment, even if you begin to feel better after a few days. Also, this medicine works best when there is a constant amount in the blood. To help keep the amount constant, you must receive this medicine on a regular schedule.

Precautions While Using This Medicine:

Your doctor will check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood and urine tests may be needed to check for unwanted effects.

If your symptoms do not improve within a few days or if they become worse, check with your doctor.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are receiving this medicine.

Call your doctor right away if you develop chest pain, dry cough, fever, general feeling of tiredness or weakness, rapid breathing, trouble breathing, or skin rash after receiving this medicine. These maybe symptoms of a serious condition called eosinophilic pneumonia.

Daptomycin injection may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop receiving this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. If you have any questions or if mild diarrhea continues or gets worse, check with your doctor.

If you have unexplained muscle pain, tenderness, or weakness while receiving this medicine, check with your doctor right away.

This medicine may cause serious skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), which can damage organs, including the liver, kidney, or heart. Check with your doctor if you have black, tarry stools, chest pain, chills, cough, fever, painful or difficult urination, sore throat, sores, ulcers, or white spots on the lips or in the mouth, swollen glands, trouble breathing, unusual bleeding, bruising, tiredness, or weakness.

This medicine may cause a kidney problem called tubulointerstitial nephritis. Check with your doctor right away if you have a bloody or cloudy urine, fever, skin rash, swelling of the feet or lower legs, or greatly decreased frequency of urination or amount of urine.

Check with your doctor right away if you are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet after receiving this medicine. These could be symptoms of a condition called peripheral neuropathy.

Before you have any medical tests, tell the medical doctor in charge that you are receiving this medicine. The results of some tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This especially 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

fever

tingling of the hands or feet

unusual weight gain or loss

Less common

Agitation

black, tarry stools

bladder pain

bloody or cloudy urine

blurred vision

chest pain, discomfort, or tightness

chills

confusion

cough

decreased awareness or responsiveness

decreased frequency or amount of urine

depression

diarrhea

difficult, burning, or painful urination

dilated neck veins

dizziness

dry mouth

dryness and peeling of the skin

fainting

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

fast heartbeat

frequent urge to urinate

headache

hostility

increased blood pressure

increased thirst

irregular breathing

irregular heartbeat

irritability

itching in the genital or other skin areas

itching, pain, redness, swelling, tenderness, or warmth on the skin

lightheadedness

loss of appetite

loss of consciousness

lower back or side pain

mood changes

muscle pain, cramps, or twitching

nausea

nervousness

numbness or tingling in the hands, feet, or lips

pale skin

pounding in the ears

rapid, shallow breathing

seizures

severe sleepiness

skin rash

slow or fast heartbeat

sneezing

sores, ulcers, or white spots on the lips or in the mouth

sore throat

stomach pain

sweating

swollen glands

trouble breathing

unusual bleeding or bruising

unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

vomiting of blood or material that looks like coffee grounds

Rare

Bleeding gums

blistering, peeling, or loosening of the skin

blood in the urine or stools

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

clay-colored stools

dark urine

difficulty with moving

drowsiness

eye pain

feeling of warmth

feeling unusually cold

general feeling of illness

hives

hoarseness

increase in bone pain

irritation

joint pain, stiffness, or swelling

loss of appetite

mood or mental changes

no blood pressure or pulse

pinpoint red spots on the skin

rapid heartbeat

redness of the face, neck, arms, and occasionally, upper chest

shivering

skin rash, encrusted, scaly, and oozing

stopping of the heart

swollen, painful, or tender lymph glands in the neck, armpit, or groin

trembling

trouble swallowing

twitching, twisting, uncontrolled repetitive movements of the tongue, lips, face, arms, or legs

unpleasant breath odor

yellow eyes or skin

Incidence not known

Diarrhea, watery, and severe, which may also be bloody

dry cough

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

stomach cramps or tenderness

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

Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

difficulty having a bowel movement

Less common

Anxiety

back pain

blurred vision

cold sweats

cool, pale skin

depression

flushed, dry skin

fruit-like breath odor

increased hunger

increased urination

itching of the vagina or outside genitals

lack or loss of strength

limb pain

nervousness

nightmares

pain during sexual intercourse

shakiness

slurred speech

sweating

thick, white, curd-like vaginal discharge without odor or with mild odor

trouble sleeping

Rare

Bad, unusual, or unpleasant (after) taste

belching

change in taste

continuing ringing or buzzing or other unexplained noise in the ears

excess air or gas in the stomach or intestines

feeling of constant movement of self or surroundings

feeling of fullness

hearing loss

heartburn

indigestion

pain or discomfort in the chest, upper stomach, or throat

passing gas

pressure in the stomach

red, sore eyes

seeing, hearing, or feeling things that are not there

sensation of spinning

sore mouth or tongue

swelling of the stomach area

swelling or inflammation of the mouth

white patches in the mouth or on the tongue

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.