Consumer medicine information

1. Why am I using Nab-PACLITAXEL JUNO?

Nab-PACLITAXEL JUNO contains the active ingredient paclitaxel. Nab-PACLITAXEL JUNO is used to treat cancer of the breast, non-small cell cancer of the lungs and pancreatic cancer.
For more information, see Section 1. Why am I using Nab-PACLITAXEL JUNO? in the full CMI.

2. What should I know before I use Nab-PACLITAXEL JUNO?

Do not use if you are allergic to paclitaxel or any of the ingredients listed at the end of this leaflet or if you have a very low white blood cell (WBC) count.
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 use Nab-PACLITAXEL JUNO? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Nab-PACLITAXEL 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 is Nab-PACLITAXEL JUNO given?

Your doctor will decide what dose of Nab-PACLITAXEL JUNO you will receive. This depends on your condition and other factors. Nab-PACLITAXEL JUNO may be used alone or in combination with other anticancer agents. More instructions can be found in Section 4. How is Nab-PACLITAXEL JUNO given? in the full CMI.

5. What should I know while using Nab-PACLITAXEL JUNO?

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention. Some of the symptoms of a serious allergic reaction are: shortness of breath, coughing, wheezing or difficulty breathing, swelling of the face, lips, tongue, or other parts of the body, rash, itching or hives on the skin, yellowing of the skin or eyes.
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

Nanoparticle albumin-bound paclitaxel.

2 Qualitative and Quantitative Composition

Nab-Paclitaxel Juno powder for suspension for infusion is an albumin nanoparticle form of paclitaxel with a mean particle size of approximately 130 nanometres. Paclitaxel exists in the nanoparticles in a non-crystalline, amorphous state. Each vial of Nab-Paclitaxel Juno contains paclitaxel and human albumin in the ratio of 1:9. The paclitaxel is contained within nanoparticles that consist of a majority of paclitaxel bound to human albumin.
Each single-use vial contains the following: Paclitaxel 100 mg. Nab-Paclitaxel Juno is free of solvents.
100 mg vial. The reconstituted medicinal product contains approximately 85 mg sodium per vial when reconstituted with 0.9% sodium chloride.
The active agent in Nab-Paclitaxel Juno is paclitaxel, a natural product with antitumour activity. Paclitaxel is obtained from Taxus species.
Excipient(s) with known effect. Not applicable. For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Nab-Paclitaxel Juno is supplied as a sterile white to yellow lyophilised cake or powder in a 50 mL USP Type I flint glass vial with 20 mm grey bromobutyl rubber stopper and 20 mm aluminium flip off seal.

4 Clinical Particulars

4.9 Overdose

There is no known antidote for paclitaxel overdosage. The primary anticipated complications of overdosage would consist of bone marrow suppression, sensory neurotoxicity, and mucositis.
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. Paclitaxel has been shown to be clastogenic in vitro (chromosome aberrations in human lymphocytes) and in vivo (micronucleus test in mice). Paclitaxel was not mutagenic in the Ames test or the CHO/HGPRT gene mutation assay.
Carcinogenicity. The carcinogenic potential of paclitaxel powder for suspension for infusion has not been studied.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. The empirical formula for paclitaxel is C₄₇H₅₁NO₁₄. The chemical name for paclitaxel is 5β,20-Epoxy-1,7β-dihydroxy-9-oxotax-11-ene-2α, 4, 10β,13α-tetrayl 4,10-diacetate 2-benzoate 13[(2R,3S)-3-(benzoylamino)-2-hydroxy-3- phenylpropanoate]. Paclitaxel has the following chemical structure:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSPACACC.gif CAS number. The CAS Number for paclitaxel is 33069-62-4.

7 Medicine Schedule (Poisons Standard)

Prescription only medicine (Schedule 4).

Summary Table of Changes

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