Pembrolizumab and berahyaluronidase alfa
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Specialty pharmacy: therapy management checklist, storage and cold chain, dosing calendar, Medicare Part D coverage.
Endoglycosidase, Programmed Death Receptor-1 Blocking Antibody
Dosing in kidney impairment
Patients who are cisplatin-eligible Cisplatin ineligibility is defined as meeting at least one of the following criteria: Creatinine clearance of less than 60 mL/min, ECOG PS 2 or higher, Grade 2 or higher hearing loss, NYHA Class III or higher heart failure, or Grade 2 or higher peripheral neuropathy. : Neoadjuvant: Administer KEYTRUDA QLEX 395 mg/4,800 units every 3 weeks for 4 doses or 790 mg/9,600 units every 6 weeks for 2 doses in combination with enfortumab vedotin-ejfv or until disease progression that precludes curative-intent cystectomy or unacceptable toxicity Adjuvant: Administer KEYTRUDA QLEX 395 mg/4,800 units every 3 weeks for 13 doses or 790 mg/9,600 units every 6 weeks for 7 doses in combination with enfortumab vedotin-ejfv or until disease recurrence or unacceptable toxicity Patients who are cisplatin-ineligible : Neoadjuvant: Administer KEYTRUDA QLEX 395 mg/4,800 units every 3 weeks for 3 doses in combination with enfortumab vedotin or until disease progression that precludes curative-intent cystectomy or unacceptable toxicity.
| Indication | Recommended Dosage of KEYTRUDA QLEX | Duration/Timing of Treatment |
|---|---|---|
| Monotherapy | ||
| Adult patients with unresectable or metastatic melanoma | 395 mg/4,800 units every 3 weeks or 790 mg/9,600 units every 6 weeks | Until disease progression or unacceptable toxicity |
| Adjuvant treatment of adult patients with melanoma, NSCLC, or RCC | 395 mg/4,800 units every 3 weeks or 790 mg/9,600 units every 6 weeks | Until disease recurrence, unacceptable toxicity, or up to 12 months |
| Adult patients with NSCLC, HNSCC, locally advanced or metastatic Urothelial Carcinoma, MSI-H or dMMR Cancer, MSI-H or dMMR CRC, MSI-H or dMMR Endometrial Carcinoma, Esophageal Cancer, Cervical Cancer, HCC, MCC, TMB-H Cancer, or cSCC | 395 mg/4,800 units every 3 weeks or 790 mg/9,600 units every 6 weeks | Until disease progression, unacceptable toxicity, or up to 24 months |
| Adult patients with high-risk BCG- unresponsive NMIBC | 395 mg/4,800 units every 3 weeks or 790 mg/9,600 units every 6 weeks | Until persistent or recurrent high-risk NMIBC, disease progression, unacceptable toxicity, or up to 24 months |
| Pediatric patientsThe recommended dosage for melanoma, MSI-H or dMMR cancer, MCC and TMB-H cancer has not been established in pediatric patients 12 years and older who weigh 40 kg or less [see Use in Specific Populations (8.4)]. (12 years and older who weigh greater than 40 kg) with MSI-H or dMMR Cancer, MCC, or TMB- H Cancer | 395 mg/4,800 units every 3 weeks or 790 mg/9,600 units every 6 weeks | Until disease progression, unacceptable toxicity, or up to 24 months |
| Pediatric patients (12 years and older who weigh greater than 40 kg) for adjuvant treatment of melanoma | 395 mg/4,800 units every 3 weeks or 790 mg/9,600 units every 6 weeks | Until disease recurrence, unacceptable toxicity, or up to 12 months |
| Combination TherapyRefer to the Prescribing Information for the agents administered in combination with KEYTRUDA QLEX for recommended dosing information, as appropriate. | ||
| Adult patients with resectable NSCLC | 395 mg/4,800 units every 3 weeks or 790 mg/9,600 units every 6 weeks Administer KEYTRUDA QLEX prior to chemotherapy when given on the same day. | Neoadjuvant treatment in combination with chemotherapy for 12 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA QLEX as a single agent after surgery for 39 weeks or until disease recurrence or unacceptable toxicity |
| Adult patients with NSCLC, MPM, HNSCC, HER2-negative Gastric Cancer, Esophageal Cancer, or BTC | 395 mg/4,800 units every 3 weeks or 790 mg/9,600 units every 6 weeks Administer KEYTRUDA QLEX prior to chemotherapy when given on the same day. | Until disease progression, unacceptable toxicity, or up to 24 months |
| Adult patients with locally advanced or metastatic urothelial cancer | 395 mg/4,800 units every 3 weeks or 790 mg/9,600 units every 6 weeks Administer KEYTRUDA QLEX after enfortumab vedotin-ejfv when given on the same day. | Until disease progression, unacceptable toxicity, or up to 24 months |
| Adult patients with locally advanced HNSCC | 395 mg/4,800 units every 3 weeks or 790 mg/9,600 units every 6 weeks Administer KEYTRUDA QLEX prior to cisplatin when given on the same day. | Neoadjuvant: Administer KEYTRUDA QLEX for 6 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity. Adjuvant: Administer KEYTRUDA QLEX in combination with RT with or without cisplatin.Continue KEYTRUDA QLEX as a single agent. Continue KEYTRUDA QLEX until disease recurrence or unacceptable toxicity or up to one year |
| Adult patients with MIBC | 395 mg/4,800 units every 3 weeks or 790 mg/9,600 units every 6 weeks Administer KEYTRUDA QLEX after enfortumab vedotin-ejfv when given on the same day. | Patients who are cisplatin-eligibleCisplatin ineligibility is defined as meeting at least one of the following criteria: Creatinine clearance of less than 60 mL/min, ECOG PS 2 or higher, Grade 2 or higher hearing loss, NYHA Class III or higher heart failure, or Grade 2 or higher peripheral neuropathy.: Neoadjuvant: Administer KEYTRUDA QLEX 395 mg/4,800 units every 3 weeks for 4 doses or 790 mg/9,600 units every 6 weeks for 2 doses in combination with enfortumab vedotin-ejfv or until disease progression that precludes curative-intent cystectomy or unacceptable toxicity Adjuvant: Administer KEYTRUDA QLEX 395 mg/4,800 units every 3 weeks for 13 doses or 790 mg/9,600 units every 6 weeks for 7 doses in combination with enfortumab vedotin-ejfv or until disease recurrence or unacceptable toxicityPatients who are cisplatin-ineligible: Neoadjuvant: Administer KEYTRUDA QLEX 395 mg/4,800 units every 3 weeks for 3 doses in combination with enfortumab vedotin or until disease progression that precludes curative-intent cystectomy or unacceptable toxicity. Adjuvant: Administer KEYTRUDA QLEX 395 mg/4,800 units every 3 weeks for 14 doses or 790 mg/9,600 units every 6 weeks for 7 doses in combination with enfortumab vedotin or until disease recurrence or unacceptable toxicity |
| Adult patients with HER2-positive Gastric Cancer | 395 mg/4,800 units every 3 weeks or 790 mg/9,600 units every 6 weeks Administer KEYTRUDA QLEX prior to trastuzumab and chemotherapy when given on the same day. | Until disease progression, unacceptable toxicity, or up to 24 months |
| Adult patients with Cervical Cancer | 395 mg/4,800 units every 3 weeks or 790 mg/9,600 units every 6 weeks Administer KEYTRUDA QLEX prior to chemoradiotherapy or prior to chemotherapy with or without bevacizumab when given on the same day. | Until disease progression, unacceptable toxicity, or for KEYTRUDA QLEX, up to 24 months |
| Adult patients with RCC | 395 mg/4,800 units every 3 weeks or 790 mg/9,600 units every 6 weeks Administer KEYTRUDA QLEX in combination with axitinib 5 mg orally twice dailyWhen axitinib is used in combination with KEYTRUDA QLEX, dose escalation of axitinib above the initial 5 mg dose may be considered at intervals of six weeks or longer. or Administer KEYTRUDA QLEX in combination with lenvatinib 20 mg orally once daily. | Until disease progression, unacceptable toxicity, or for KEYTRUDA QLEX, up to 24 months |
| Adult patients with Endometrial Carcinoma | 395 mg/4,800 units every 3 weeks or 790 mg/9,600 units every 6 weeks Administer KEYTRUDA QLEX prior to carboplatin and paclitaxel when given on the same day. or Administer KEYTRUDA QLEX in combination with lenvatinib 20 mg orally once daily. | Until disease progression, unacceptable toxicity, or for KEYTRUDA QLEX, up to 24 months |
| Adult patients with high-risk early-stage TNBC | 395 mg/4,800 units every 3 weeks or 790 mg/9,600 units every 6 weeks Administer KEYTRUDA QLEX prior to chemotherapy when given on the same day. | Neoadjuvant treatment in combination with chemotherapy for 24 weeks (8 doses of 395 mg/4,800 units every 3 weeks or 4 doses of 790 mg/9,600 units every 6 weeks) or until disease progression or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA QLEX as a single agent for up to 27 weeks (9 doses of 395 mg/4,800 units every 3 weeks or 5 doses of 790 mg/9,600 units every 6 weeks) or until disease recurrence or unacceptable toxicityPatients who experience disease progression or unacceptable toxicity related to KEYTRUDA QLEX with neoadjuvant treatment in combination with chemotherapy should not receive adjuvant single agent KEYTRUDA QLEX. |
| Adult patients with unresectable locally advanced or metastatic TNBC | 395 mg/4,800 units every 3 weeks or 790 mg/9,600 units every 6 weeks | Until disease progression, unacceptable toxicity, or up to 24 months |
| Adult patients with locally recurrent unresectable or metastatic TNBC | 395 mg/4,800 units every 3 weeks or 790 mg/9,600 units every 6 weeks Administer KEYTRUDA QLEX prior to chemotherapy when given on the same day. | Until disease progression, unacceptable toxicity, or up to 24 months |
| Adult patients with Ovarian Cancer | 395 mg/4,800 units every 3 weeks or 790 mg/9,600 units every 6 weeks Administer KEYTRUDA QLEX prior to paclitaxel with or without bevacizumab when given on the same day. | Until disease progression, unacceptable toxicity, or up to 24 months |
| Adjuvant treatment of adult patients with ccRCC | 395 mg/4,800 units every 3 weeks or 790 mg/9,600 units every 6 weeks Administer KEYTRUDA QLEX in combination with belzutifan 120 mg orally once daily. | Until disease recurrence, unacceptable toxicity, or up to 12 months |
| Adverse Reaction | SeverityBased on Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 | Dosage Modification |
|---|---|---|
| ALT = alanine aminotransferase, AST = aspartate aminotransferase, DRESS = Drug Rash with Eosinophilia and Systemic Symptoms, SJS = Stevens Johnson Syndrome, TEN = toxic epidermal necrolysis, ULN = upper limit normal | ||
| Immune-Mediated Adverse Reactions [see Warnings and Precautions (5.1)] | ||
| Pneumonitis | Grade 2 | WithholdResume in patients with complete or partial resolution (Grades 0 to 1) after corticosteroid taper. Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone to 10 mg per day or less (or equivalent) within 12 weeks of initiating steroids. |
| Grade 3 or 4 | Permanently discontinue | |
| Colitis | Grade 2 or 3 | Withhold |
| Grade 4 | Permanently discontinue | |
| Hepatitis with no tumor involvement of the liver | AST or ALT increases to more than 3 and up to 8 times ULN or Total bilirubin increases to more than 1.5 and up to 3 times ULN | Withhold |
| For liver enzyme elevations in patients treated with combination therapy with axitinib, see Table 3. | AST or ALT increases to more than 8 times ULN or Total bilirubin increases to more than 3 times ULN | Permanently discontinue |
| Hepatitis with tumor involvement of the liverIf AST and ALT are less than or equal to ULN at baseline, withhold or permanently discontinue KEYTRUDA QLEX based on recommendations for hepatitis with no liver involvement. | Baseline AST or ALT is more than 1 and up to 3 times ULN and increases to more than 5 and up to 10 times ULN or Baseline AST or ALT is more than 3 and up to 5 times ULN and increases to more than 8 and up to 10 times ULN | Withhold |
| ALT or AST increases to more than 10 times ULN or Total bilirubin increases to more than 3 times ULN | Permanently discontinue | |
| Endocrinopathies | Grade 3 or 4 | Withhold until clinically stable or permanently discontinue depending on severity |
| Nephritis with Renal Dysfunction | Grade 2 or 3 increased blood creatinine | Withhold |
| Grade 4 increased blood creatinine | Permanently discontinue | |
| Exfoliative Dermatologic Conditions | Suspected SJS, TEN, or DRESS | Withhold |
| Confirmed SJS, TEN, or DRESS | Permanently discontinue | |
| Myocarditis | Grade 2, 3, or 4 | Permanently discontinue |
| Neurological Toxicities | Grade 2 | Withhold |
| Grade 3 or 4 | Permanently discontinue | |
| Other Adverse Reactions | ||
| Hypersensitivity and Administration-Related Systemic Reactions [see Warnings and Precautions (5.2)] | Grade 1 or 2 | Interrupt injection (if not already fully administered). If symptoms resolve, resume injection |
| Grade 3 or 4 | Permanently discontinue | |
Preparation and administration
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Important Dosage and Administration Information KEYTRUDA QLEX has different recommended dosage and administration instructions than intravenous pembrolizumab. To reduce the risk of medication errors, check the vial labels to ensure that the drug being prepared and administered is KEYTRUDA QLEX for subcutaneous use and not intravenous pembrolizumab.
Do not substitute KEYTRUDA QLEX with intravenous pembrolizumab because they have different recommended dosages and routes of administration. Patients receiving intravenous pembrolizumab can switch to subcutaneous KEYTRUDA QLEX at their next scheduled dose. Patients receiving subcutaneous KEYTRUDA QLEX can switch to intravenous pembrolizumab at their next scheduled dose.
Administer KEYTRUDA QLEX as a subcutaneous injection into the thigh or abdomen, avoiding the 5 cm area around the navel. Every 3-week dosing (395 mg/4,800 units) : inject 2.4 mL subcutaneously over 1 minute. Treatment duration is provided in Recommended Dosage (Table 1). Every 6-week dosing (790 mg/9,600 units): inject 4.8 mL subcutaneously over 2 minutes.
Treatment duration is provided in Recommended Dosage (Table 1). Inject into healthy skin and never into areas where the skin is red, bruised, tender, or hard. Ensure the injection site is at least 2.5 cm from the previous injection site. During treatment with KEYTRUDA QLEX, do not administer other medications for subcutaneous use at the same site as KEYTRUDA QLEX.
Do not administer KEYTRUDA QLEX intravenously. KEYTRUDA QLEX must be administered by a healthcare provider.
Preparation KEYTRUDA QLEX is a ready-to-use solution. Do not dilute KEYTRUDA QLEX. Do not shake. Preparation of the Syringe Remove KEYTRUDA QLEX vial from refrigerated storage [2°C to 8°C (36°F to 46°F)] and allow it to equilibrate to room temperature [20°C to 25°C (68°F to 77°F)] for at least 30 minutes. Prior to preparation for administration, if needed, the unpunctured vial may be stored at room temperature for up to 24 hours.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The solution is clear to slightly opalescent, colorless to slightly yellow. Discard the vial if visible particles are observed. Use a sterile, polypropylene or polycarbonate syringe and a stainless steel transfer needle (18 to 21 gauge) to withdraw KEYTRUDA QLEX from the vial.
Every 3-week dosing (395 mg pembrolizumab/4,800 units berahyaluronidase alfa) : withdraw 2.4 mL into the syringe. Every 6-week dosing (790 mg pembrolizumab/9,600 units berahyaluronidase alfa) : withdraw 4.8 mL into the syringe. To avoid needle clogging, change the needle to a 25 to 30 gauge, ½-inch, stainless steel hypodermic injection needle immediately prior to subcutaneous injection.
Discard any unused portion left in the vial. Storage of Prepared Syringe The product does not contain a preservative and should be used immediately after withdrawing from the vial. If not used immediately, store the syringe containing KEYTRUDA QLEX with the transfer needle and cap in place: At room temperature 20°C to 25°C (68°F to 77°F) for up to 8 hours, or In the refrigerator at 2°C to 8°C (36°F to 46°F), protected from light for up to 96 hours.
The 96-hour period may include up to 8 hours at room temperature. Discard if storage time exceeds these limits. If refrigerated, allow the filled syringe to come to room temperature for at least 30 minutes prior to administration. Do not freeze.
Drug interactions
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- Pembrolizumab and berahyaluronidase alfa
Contraindications
4 CONTRAINDICATIONS KEYTRUDA QLEX is contraindicated in patients with known hypersensitivity to berahyaluronidase alfa, hyaluronidase or to any of its excipients. KEYTRUDA QLEX is contraindicated in patients with known hypersensitivity to berahyaluronidase alfa, hyaluronidase or to any of its excipients. ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for pembrolizumab and berahyaluronidase alfa. Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Based on its mechanism of action [see Clinical Pharmacology (12.1) ] , KEYTRUDA QLEX can cause fetal harm when administered to a pregnant woman. There are no available human data informing the risk of embryo-fetal toxicity. In animal models, the PD-1/PD-L1 signaling pathway is important in the maintenance of pregnancy through induction of maternal immune tolerance to fetal tissue (see Data ) . Human IgG4 (immunoglobulins) are known to cross the placenta; therefore, pembrolizumab has the potential to be transmitted from the mother to the developing fetus. Advise pregnant women of the potential risk to a fetus. In the U.S.
general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data KEYTRUDA QLEX for subcutaneous injection contains pembrolizumab and berahyaluronidase alfa [see Description (11) ] . Pembrolizumab: Animal reproduction studies have not been conducted with pembrolizumab to evaluate its effect on reproduction and fetal development. A literature-based assessment of the effects of the PD-1 pathway on reproduction demonstrated that a central function of the PD-1/PD-L1 pathway is to preserve pregnancy by maintaining maternal immune tolerance to the fetus.
Blockade of PD-L1 signaling has been shown in murine models of pregnancy to disrupt tolerance to the fetus and to result in an increase in fetal loss; therefore, potential risks of administering pembrolizumab during pregnancy include increased rates of abortion or stillbirth. As reported in the literature, there were no malformations related to the blockade of PD-1 signaling in the offspring of these animals; however, immune-mediated disorders occurred in PD-1 knockout mice. Based on its mechanism of action, fetal exposure to pembrolizumab may increase the risk of developing immune-mediated disorders or of altering the normal immune response.
Berahyaluronidase alfa: In an embryo-fetal development study, pregnant rabbits were administered daily subcutaneous injections of 138,600, 403,200, or 1,209,600 U/kg berahyaluronidase alfa during the period of organogenesis (gestation days 6 to 19). Berahyaluronidase alfa caused delayed fetal development at doses ≥403,200 U/kg, which is >2,500 times higher than the human dose (U/kg basis). Increased post-implantation loss and visceral malformations (supernumerary fissure lung lobe) were observed at 1,209,600 U/kg, which is >7,500 times higher than the human dose. In an embryo-fetal development study in rats,…
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
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