Consumer medicine information

1. Why am I given Daptomycin Juno?

Daptomycin Juno contains the active ingredient Daptomycin. Daptomycin Juno is used in adults and children (1 to 17 years of age) to treat complicated infections of the skin and the tissues under the skin. It is also used in adults to treat blood infections and infections of the tissues that line the inside of the heart. For more information, see Section 1. Why am I given Daptomycin Juno? in the full CMI.

2. What should I know before I am given Daptomycin Juno?

Do not use if you have ever had an allergic reaction to Daptomycin or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I am given Daptomycin Juno? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Daptomycin Juno and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How will I be given Daptomycin Juno?

Daptomycin Juno will be given to you by a doctor or a nurse as it needs to be given as an injection or infusion into a vein. The dose will depend on how much you weigh and the type of infection being treated. More instructions can be found in Section 4. How will I be given Daptomycin Juno? in the full CMI.

5. What should I know while using Daptomycin Juno?

6. Are there any side effects?

Side effects of this medicine may include oral or vaginal thrush; inflammation and irritation of the vagina; fungal infections; pain; itchiness or redness at the injection site; tiredness; trembling; decreased appetite; dizziness, blurred vision, lightheadedness; spinning sensation; headache; flushes; mild stomach upsets such as indigestion, nausea, vomiting; abdominal swelling or bloating; flatulence; constipation, diarrhoea; taste disturbance; eye irritation; difficulty in sleeping; anxiety; urinary tract infection; high or low blood pressure; sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing; difficulty breathing, new or worsening cough or fever; unexplained muscle tenderness, weakness or cramps; tingling, burning or numbness of arms, hands, legs or feet; difficulty moving the arms and/or legs; changes in heart rhythm; yellowing of the skin and eyes; kidney problems or failure; fainting; unusual bleeding in the skin and bruising; pus filled bumps; shivering or chills; blistering rash. For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Daptomycin.

2 Qualitative and Quantitative Composition

Daptomycin Juno is supplied in a single-use 10 mL vial, as a sterile, preservative-free, pale yellow to light brown, lyophilised cake or powder containing at least 500 mg/g of daptomycin for intravenous (IV) use following reconstitution with 0.9% sodium chloride injection.
Daptomycin has a high aqueous solubility (> 1 g/mL).
The only inactive ingredient is sodium hydroxide, which is used in minimal quantities for pH adjustment.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Powder for injection.
Sterile, preservative-free, pale yellow to light brown, lyophilised cake or powder.

4 Clinical Particulars

4.9 Overdose

In the event of overdose, supportive care is advised. Daptomycin is slowly cleared from the body by haemodialysis (approximately 15% of the administered dose is removed over 4 hours) or by peritoneal dialysis (approximately 11% of the administered dose is removed over 48 hours).
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Daptomycin was not mutagenic or clastogenic in a battery of in vivo and in vitro genotoxicity tests comprising mutation in bacteria and mammalian cells, chromosomal aberrations and DNA damage in mammalian cells, a bone marrow micronucleus assay in mice and a sister chromatid exchange assay in Chinese hamsters.
Carcinogenicity. Long-term carcinogenicity studies in animals have not been conducted to evaluate the carcinogenic potential of daptomycin.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Daptomycin is the active ingredient in Daptomycin Juno. It is a cyclic lipopeptide antibacterial agent derived from the fermentation of Streptomyces roseosporus.
Active ingredient: daptomycin.
Chemical names: N-decanoyl-L-tryptophyl-D-asparaginyl-L-aspartyl-L-threonylglycyl- L-ornithyl-L-aspartyl-D-alanyl-L-aspartylglycyl-D-seryl-threo-3- methyl- L-glutamyl-3-anthraniloyl-L-alanine Ɛ1-lactone.
Molecular weight: 1620.67.
Molecular formula: C₇₂H₁₀₁N₁₇O₂₆.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSDAPTOM.gif CAS number. 103060-53-3.

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine (Schedule 4).

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/DAPJUNST.gif