Cubicin RF (Intravenous)

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 stopping 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.

Your doctor will closely monitor your progress while you are receiving this medicine. This will help your doctor determine if the medicine is working properly and whether you should continue treatment. Blood and urine tests may be necessary to check for side effects.

If your symptoms do not get better within a few days or if they worsen, contact your doctor.

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

Call your doctor immediately if you develop chest pain, dry cough, fever, feeling unusually tired or weak, rapid breathing, trouble breathing, or a skin rash after receiving this medicine. These may be signs of a serious condition called eosinophilic pneumonia.

Daptomycin injection may cause diarrhea, which can sometimes be severe. This may happen 2 months or more after you stop this medicine. Do not take any medicine for diarrhea without first checking with your doctor. If you have questions or if mild diarrhea continues or worsens, consult your doctor.

If you experience unexplained muscle pain, tenderness, or weakness while receiving this medicine, contact your doctor right away.

This medicine may cause serious skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), which can harm organs like the liver, kidney, or heart. Contact 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 lead to a kidney issue called tubulointerstitial nephritis. Contact your doctor immediately if you notice bloody or cloudy urine, fever, skin rash, swelling in the feet or lower legs, or a significant decrease in urine frequency or amount.

Contact your doctor right away if you experience burning, numbness, tingling, or painful sensations in your arms, hands, legs, or feet after receiving this medicine. These could indicate a condition called peripheral neuropathy.

Before undergoing any medical tests, inform the medical doctor in charge that you are receiving this medicine. The results of some tests may be influenced by this medicine.

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

In deciding to use a medicine, you and your doctor must weigh the risks against the benefits. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you have, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies to date have not shown any specific problems that would limit the use of daptomycin injection in children. However, safety and effectiveness have not been established in children younger than 1 year old.

Geriatric

Studies to date have not shown any specific problems that would limit the use of daptomycin injection in older adults. However, older patients are more likely to experience increased unwanted side effects, which may require caution when using daptomycin injection.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together, while others may be used together even if an interaction might occur. In these cases, your doctor may want to adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below while receiving this medicine. The following interactions have been selected based on 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 necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or frequency of one or both medicines.

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

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at or around mealtime or with certain types of food due to potential interactions. Drinking alcohol or using tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Be sure to tell your doctor about any other medical issues, especially:

• Diarrhea or
• Muscle problems (e.g., myopathy, rhabdomyolysis) or
• Nerve problems (e.g., neuropathy)—Use with caution. May worsen these conditions.

• 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 stronger due to slower removal of the medicine from the body.

• Lung or breathing problems (e.g., pneumonia)—This medicine is not indicated to treat patients with this condition.

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

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.

In the U.S.

• Cubicin
• Cubicin RF
• Dapzura RT

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antibiotic

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.