Dalvance

Pregnancy Category: C

No evidence of embryo or fetal toxicity was found in the rat or rabbit at a dose of 15 mg/kg/day (1.2 and 0.7 times the human dose on an exposure basis, respectively)

Delayed fetal maturation was observed in the rat at a dose of 45 mg/kg/day (3.5 times the human dose on an exposure basis)

Lactation: Unknown if distributed in human breast milk

Excreted in milk of lactating rats

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

IV Compatabilities

Dextrose 5%

IV Incompatabilities

Saline-based solutions (precipitation occurs)

Compatibility of reconstituted dalbavancin with IV medications, additives, or substances other than 5% dextrose has not been established

IV Preparation

Reconstitution

• Reconstitute under aseptic conditions, using 25 mL of sterile water for injection for each 500-mg vial
• To avoid foaming, alternate between gentle swirling and inversion of the vial until its contents are completely dissolved
• Do NOT shake
• Reconstituted vial contains 20 mg/mL
• Reconstituted solution should appear clear and colorless to yellow

Dilution

• Aseptically transfer the required dose of reconstituted solution from the vial(s) to IV bag or bottle containing D5W
• Final concentration of diluted solution must be between 1 mg/mL and 5 mg/mL
• Discard any unused portion of the reconstituted vials

IV Administration

Visually inspect for particulate matter before infusion

If common IV line is being used to administer other drugs in addition to dalbavancin, the line should be flushed before and after each dose

Infuse IV over 30 minutes

Infusion-related reactions associated with rapid IV infusion

Storage

Reconstituted vials or diluted solution

• Store either refrigerated at 2-8°C (36-46 °F), or at controlled room temperature 20-25°C (68-77°F)
• Do not freeze
• Total time from reconstitution to dilution to administration should not exceed 48 hr

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 any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• diarrhea that is watery or bloody.

Common side effects may include:

• headache;

• nausea; or

• diarrhea.

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 dalbavancin, 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.

Skin and Skin Structure Infections

Treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Staphylococcus aureus (including methicillin-resistant S. aureus [MRSA; also known as oxacillin-resistant S. aureus or ORSA] and methicillin-susceptible S. aureus), Streptococcus pyogenes (group A β-hemolytic streptococci, GAS), S. agalactiae (group B streptococci, GBS), or S. anginosus group (includes S. anginosus, S. intermedius, and S. constellatus).1 5

In the U.S.

• Dalvance

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antibacterial

Chemical Class: Glycopeptide

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Loose stools (diarrhea).
• Headache.
• Upset stomach.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• 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 Dalvance 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 Dalvance. 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

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

Applies to dalbavancin: intravenous powder for solution

Along with its needed effects, dalbavancin (the active ingredient contained in Dalvance) 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 immediately if any of the following side effects occur while taking dalbavancin:

• Abdominal or stomach pain or tenderness
• back pain
• black, tarry stools
• bleeding gums
• blood in the urine or stools
• chest pain or tightness
• chills
• clay colored stools
• cough
• dark urine
• decreased appetite
• difficulty swallowing
• dizziness
• fast heartbeat
• feeling of warmth
• fever
• headache
• hives, welts, itching, or rash
• loss of appetite
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness of the face, neck, arms, and occasionally, upper chest
• redness of the skin
• severe abdominal or stomach cramps and pain
• sore mouth or tongue
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swelling of the feet or lower legs
• swollen glands
• tightness in the chest
• troubled breathing with exertion
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting of blood or material that looks like coffee grounds
• watery and severe diarrhea, which may also be bloody
• yellow eyes or skin

Some side effects of dalbavancin 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:

• Diarrhea

• Anxiety
• blurred vision
• cold sweats
• coma
• confusion
• cool, pale skin
• depression
• increased hunger
• nightmares
• seizures
• shakiness
• slurred speech