Consumer medicine information

1. Why am I using KEYTRUDA?

KEYTRUDA contains the active ingredient pembrolizumab. KEYTRUDA is used to treat multiple kinds of cancer.
For more information, see Section 1. Why am I using KEYTRUDA? in the full CMI.

2. What should I know before I use KEYTRUDA?

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 KEYTRUDA? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with KEYTRUDA and affect how it works.
For more information, see Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use KEYTRUDA?

• Your doctor will give you KEYTRUDA through an IV for about 30 minutes.

• Most people get KEYTRUDA every 3 weeks or every 6 weeks, depending on the dose you are given.

• Your doctor will decide how many treatments you need.

5. What should I know while using KEYTRUDA?

6. Are there any side effects?

Like all medicines, KEYTRUDA can cause side effects, although not everybody gets them. Your doctor will discuss these with you and will explain the risks and benefits of your treatment.
When you get KEYTRUDA, you can have some serious side effects.
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

Pembrolizumab (rch).

2 Qualitative and Quantitative Composition

One vial contains 100 mg of pembrolizumab in 4 mL of solution.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Keytruda 100 mg/4 mL concentrated injection is a sterile, preservative-free, clear to slightly opalescent, colourless to slightly yellow solution.
Not for direct infusion or injection (see Section 4.2 Dose and Method of Administration).

4 Clinical Particulars

4.9 Overdose

There is no information on overdosage with Keytruda. The maximum tolerated dose of Keytruda has not been determined. In clinical trials, patients received up to 10 mg/kg with a similar safety profile to that seen in patients receiving 2 mg/kg.
In case of overdose, patients must be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic treatment instituted.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. The genotoxic potential of pembrolizumab has not been evaluated. As a large protein molecule, pembrolizumab is not expected to interact directly with DNA or other chromosomal material.
Carcinogenicity. The carcinogenic potential of pembrolizumab has not been evaluated in long-term animal studies.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. Keytruda (pembrolizumab) is a selective humanised monoclonal antibody designed to block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. Pembrolizumab is an IgG4 kappa immunoglobulin with an approximate molecular weight of 149 kDa. Pembrolizumab is produced in Chinese hamster ovary cells by recombinant DNA technology.
CAS number. 1374853-91-4.

7 Medicine Schedule (Poisons Standard)

Prescription only medicine (Schedule 4).

Summary Table of Changes

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