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Recommended Dose of Keytruda¹

The recommended dose of KEYTRUDA in adults is either 200 mg every 3 weeks or 400 mg every
6 weeks administered as an intravenous infusion over 30 minutes.

The recommended dose of KEYTRUDA as monotherapy in paediatric patients aged 3 years and older
with cHL is 2 mg/kg bodyweight (bw) (up to a maximum of 200 mg), every 3 weeks administered as
an intravenous infusion over 30 minutes.

For use in combination, see the Summary of Product Characteristics (SmPC) for the concomitant
therapies.

Patients should be treated with KEYTRUDA until disease progression or unacceptable toxicity (and
up to maximum duration of therapy if specified for an indication). Atypical responses (i.e. an initial
transient increase in tumour size or small new lesions within the first few months followed by tumour
shrinkage) have been observed. It is recommended to continue treatment for clinically stable patients
with initial evidence of disease progression until disease progression is confirmed.

For the adjuvant treatment of melanoma or RCC, KEYTRUDA should be administered until disease
recurrence, unacceptable toxicity, or for a duration of up to one year.

For the neoadjuvant and adjuvant treatment of TNBC, patients should be treated with neoadjuvant
KEYTRUDA in combination with chemotherapy for 8 doses of 200 mg every 3 weeks or 4 doses of
400 mg every 6 weeks or until disease progression that precludes definitive surgery or unacceptable
toxicity, followed by adjuvant treatment with KEYTRUDA as monotherapy for 9 doses of 200 mg
every 3 weeks or 5 doses of 400 mg every 6 weeks or until disease recurrence or unacceptable
toxicity. Patients who experience disease progression that precludes definitive surgery or unacceptable
toxicity related to KEYTRUDA as neoadjuvant treatment in combination with chemotherapy should
not receive KEYTRUDA monotherapy as adjuvant treatment.

No dose reductions of KEYTRUDA are recommended. KEYTRUDA should be withheld or discontinued to manage adverse reactions (see Manage section).

Special Populations¹

Elderly

No dose adjustment is necessary in patients ≥ 65 years.

Renal impairment

No dose adjustment is needed for patients with mild or moderate renal impairment. KEYTRUDA has not been studied in patients with severe renal impairment.

Hepatic impairment

No dose adjustment is needed for patients with mild hepatic impairment. KEYTRUDA has not been studied in patients with moderate or severe hepatic impairment.

Paediatric population

The safety and efficacy of KEYTRUDA in children below 18 years of age have not been established except in paediatric patients with cHL.

Fertility, pregnancy and lactation¹

Women of childbearing potential

Women of childbearing potential should use effective contraception during treatment with pembrolizumab and for at least 4 months after the last dose of pembrolizumab.

Pregnancy

There are no data on the use of pembrolizumab in pregnant women. Animal reproduction studies have not been conducted with pembrolizumab; however, in murine models of pregnancy blockade of PD-L1 signalling has been shown to disrupt tolerance to the foetus and to result in an increased foetal loss. These results indicate a potential risk, based on its mechanism of action, that administration of pembrolizumab during pregnancy could cause foetal harm, including increased rates of abortion or stillbirth. Human immunoglobulins G4 (IgG4) are known to cross the placental barrier; therefore, being an IgG4, pembrolizumab has the potential to be transmitted from the mother to the developing foetus. Pembrolizumab should not be used during pregnancy unless the clinical condition of the woman requires treatment with pembrolizumab.

Breast-feeding

It is unknown whether pembrolizumab is secreted in human milk. Since it is known that antibodies can be secreted in human milk, a risk to the newborns/infants cannot be excluded. A decision should be made whether to discontinue breast-feeding or to discontinue pembrolizumab, taking into account the benefit of breast-feeding for the child and the benefit of pembrolizumab therapy for the woman.

Fertility

No clinical data are available on the possible effects of pembrolizumab on fertility. There were no notable effects in the male and female reproductive organs in monkeys based on 1-month and 6-month repeat-dose toxicity studies

• Special precautions for storage¹
• Store in a refrigerator (2°C – 8°C). Do not freeze. Store in the original carton in order to protect from light.
• The shelf life of an unopened vial is 2 years.

Preparation and administration of the infusion¹

• Do not shake the vial.
• Equilibrate the vial to room temperature (at or below 25°C).
• Prior to dilution, the vial of liquid can be out of refrigeration (temperatures at or below 25°C) for up to 24 hours.
• Parenteral medicinal products should be inspected visually for particulate matter and discolouration prior to administration. The concentrate is a clear to slightly opalescent, colourless to slightly yellow solution. Discard the vial if visible particles are observed.
• Withdraw the required volume up to 4 mL (100 mg) of concentrate and transfer into an intravenous bag containing sodium chloride 9 mg/mL (0.9%) or glucose 50 mg/mL (5%) to prepare a diluted solution with a final concentration ranging from 1 to 10 mg/mL. Each vial contains an excess fill of 0.25 mL (total content per vial 4.25 mL) to ensure the recovery of 4 mL of concentrate. Mix diluted solution by gentle inversion.
• From a microbiological point of view, the product, once diluted, should be used immediately. The diluted solution must not be frozen. If not used immediately, chemical and physical in-use stability of KEYTRUDA has been demonstrated for 96 hours at 2ºC to 8ºC. This 96-hour hold may include up to 6 hours at room temperature (at or below 25°C). If refrigerated, the vials and/or intravenous bags must be allowed to come to room temperature prior to use. Translucent to white proteinaceous particles may be seen in diluted solution.Administer the infusion solution intravenously over 30 minutes using a sterile, non-pyrogenic, low-protein binding 0.2 to 5 μm in-line or add-on filter.
• Do not co-administer other medicinal products through the same infusion line.
• KEYTRUDA is for single use only. Discard any unused portion left in the vial. 

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

1. Keytruda (pembrolizumab) Summary of Product Characteristics (SPC). 25mg/ml concentrate for infusion Last accessed June 2022