Consumer medicine information

1. Why am I receiving Blincyto?

Blincyto contains blinatumomab. It is used to treat adults, adolescents, and children with acute lymphoblastic leukaemia (ALL). For more information, see Section 1. Why am I receiving Blincyto? in the full CMI.

2. What should I know before I am given Blincyto?

Do not use if you have ever had an allergic reaction to Blincyto, 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. There are a number of circumstances in which a person should not use this medicine or may need to use caution. It is important to understand if these apply to you before receiving Blincyto (see the full CMI for more details).
For more information, see Section 2. What should I know before I am given Blincyto? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Blincyto 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 Blincyto be given?

Blincyto is given by your doctor or nurse as an infusion.
More instructions can be found in Section 4. How will Blincyto be given? in the full CMI.

5. What should I know during treatment with Blincyto?

6. Are there any side effects?

Common side effects include headache, tingling skin or numbness, rash, cough, cold like symptoms, shortness of breath, pale skin, bleeding or bruising more easily, trouble sleeping, back/bone pain, pain in hands or feet, swollen joints, hands, ankles, feet, abdomen or glands, nose bleeds, nausea, diarrhoea, vomiting, flushing, dizziness, tremor (shaking), tiredness, weight gain.
Serious side effects include fever (temperature of 38°C or above) and signs of infection, infusion-related reaction, allergic reaction, neurologic problems, inflammatory conditions, metabolic disorders, pancreas inflammation and decreased white blood cells.
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.

Boxed Warnings

Warning. The following have occurred in patients receiving Blincyto:
Cytokine release syndrome, which may be life threatening or fatal;
Neurological toxicities, which may be severe, life threatening or fatal;
Reactivation of JC viral infection.
Interrupt or discontinue Blincyto as recommended if any of these adverse events occur (see Section 4.4 Special Warnings and Precautions for Use; Section 4.2 Dose and Method of Administration).

1 Name of Medicine

Blinatumomab.

2 Qualitative and Quantitative Composition

Active substance. Each single-use vial of Blincyto contains 38.5 micrograms preservative-free blinatumomab.
After reconstitution with 3 mL of preservative-free sterile water for injections, the resulting total volume of reconstituted solution is 3.1 mL and each mL contains 12.5 micrograms (mcg) blinatumomab. The extractable amount of blinatumomab per vial is 35 micrograms in a volume of 2.8 mL reconstituted solution.
Excipients. For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Lyophilised powder for injection with IV stabiliser solution.

4 Clinical Particulars

4.9 Overdose

Overdoses have been observed including one patient who received 133-fold the recommended therapeutic dose of Blincyto delivered over a short duration. Overdoses resulted in adverse reactions that were consistent with the reactions observed at the recommended therapeutic dose and included fever, tremors, and headache. In the event of overdose, the infusion should be temporarily interrupted and patients should be monitored. Consider re-initiation of Blincyto at the correct therapeutic dose (see Section 4.2 Dose and Method of Administration).
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. No mutagenicity studies have been conducted with blinatumomab; however, blinatumomab is not expected to alter DNA or chromosomes.
Carcinogenicity. No carcinogenicity studies have been conducted with blinatumomab.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. It consists of 504 amino acids and has a molecular weight of approximately 54 kilodaltons.
The domain structure of blinatumomab is shown in the figure below:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSBLINAT.gif Using recombinant DNA technology, Blincyto is produced in a well-characterised mammalian cell (Chinese hamster ovary) culture and is purified by a series of steps that include measures to inactivate and remove viruses.
CAS number. CAS number: 853426-35-4.

7 Medicine Schedule (Poisons Standard)

S4 Prescription Medicine.

Summary Table of Changes

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