PEMRYDI RTU® (pemetrexed injection) is supplied as a ready-to-use solution1

Unique HCPCS code for billing PEMRYDI RTU®: J9324.2

PEMRYDI

PEMRYDI RTU® is available in two strengths to minimize waste1

Unit of Sale1

Unit of Sale Quantity1

NDC1

100 mg/10 mL (10 mg/mL)

Single-dose vial

70121-2453-1

500 mg/50 mL (10 mg/mL)

Single-dose vial

70121-2461-1

Unit of Sale1

Unit of Sale Quantity1

NDC1

70121-2461-1

500 mg/50 mL (10 mg/mL)

Single-dose vial

PEMRYDI RTU® is supplied as a sterile clear, colorless to pale yellow to green-yellow ready-to-use solution packaged in a USP type-I glass vial with rubber stopper and aluminum flip-off cap.1

PEMRYDI RTU® can be ordered through wholesalers and distributors.
Contact Sales@amneal.com or call (866) 525-7270 for more information.

Ready-to-use formulation makes prep more efficient

Withdraw the calculated dose* of PEMRYDI RTU® from the vial(s) and transfer to an empty IV bag. Discard any unused drug remaining in the vial.1

No Reconstitution

Save time and resources without the need for diluent.1

No Dilution

Presented at a dosable, ready-to-use concentration of 10 mg/mL.1

No Refrigeration

Stable for storage at room temperature in original packaging.1
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).1

*500 mg/m2 as an IV infusion over 10 minutes.1

PEMRYDI RTU® may be stored in an infusion bag at controlled room temperature† for up to 24 hours prior to use. Discard the infusion bag if not used within 24 hours.1

†Controlled room temperature is defined as 20°C to 25°C (68°F to 77°F).1

INDICATIONS

Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

PEMRYDI RTU® is a folate analog metabolic inhibitor indicated:

  • in combination with pembrolizumab and platinum chemotherapy for the initial treatment of patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations.
  • in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic non-squamous NSCLC.
  • as a single agent for the maintenance treatment of patients with locally advanced or metastatic non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.
  • as a single agent for the treatment of patients with recurrent metastatic non-squamous NSCLC after prior chemotherapy.

Limitations of Use:
PEMRYDI RTU® is not indicated for treatment of squamous cell non-small cell lung cancer.

Mesothelioma

PEMRYDI RTU® is indicated in combination with cisplatin for the initial treatment of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery.

IMPORTANT SAFETY INFORMATION

Contraindication

PEMRYDI RTU® is contraindicated in patients with a history of hypersensitivity reaction to pemetrexed.

Warnings and Precautions

  • Myelosuppression: PEMRYDI RTU® may cause severe bone marrow suppression resulting in cytopenia and an increased risk of infection. Do not administer when the absolute neutrophil count is less than 1500 cells/mm3 and platelets are less than 100,000 cells/mm3. Initiate supplementation with oral folic acid and intramuscular vitamin B12 to reduce the severity of hematologic and gastrointestinal toxicity of PEMRYDI RTU®.
  • Renal Failure: PEMRYDI RTU® may cause severe and sometimes fatal renal failure. Do not administer when creatinine clearance is less than 45 mL/min.
  • Bullous and Exfoliative Skin Toxicity: Permanently discontinue PEMRYDI RTU® for severe and life-threatening bullous, blistering, or exfoliating skin toxicity.
  • Interstitial Pneumonitis: Withhold PEMRYDI RTU® for acute onset of new or progressive unexplained pulmonary symptoms such as dyspnea, cough, or fever pending diagnostic evaluation. If pneumonitis is confirmed, permanently discontinue PEMRYDI RTU®.
  • Radiation Recall: May occur in patients who received radiation weeks to years previously; permanently discontinue PEMRYDI RTU® for signs of radiation recall.
  • Embryo-Fetal Toxicity: PEMRYDI RTU® can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception.

Adverse Reactions

  • The most common adverse reactions (incidence ≥ 20%) of PEMRYDI RTU® when administered as a single agent are fatigue, nausea, and anorexia.
  • The most common adverse reactions (incidence ≥ 20%) of PEMRYDI RTU® when administered with cisplatin are vomiting, neutropenia, anemia, stomatitis/pharyngitis, thrombocytopenia, and constipation.
  • The most common adverse reactions (incidence ≥ 20%) of PEMRYDI RTU® when administered with pembrolizumab and platinum chemotherapy are fatigue/asthenia, nausea, constipation, diarrhea, decreased appetite, rash, vomiting, cough, dyspnea, and pyrexia.

Drug Interactions

  • Ibuprofen increased the risk of PEMRYDI RTU® toxicity in patients with mild to moderate renal impairment. Modify the ibuprofen dosage for patients with a creatinine clearance between 45 mL/min and 79 mL/min.

Use in Specific Populations

  • Lactation: Advise not to breastfeed.

To report SUSPECTED ADVERSE REACTIONS, contact Amneal Biosciences, a division of Amneal Pharmaceuticals LLC at 1-877-835-5472 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see accompanying full Prescribing Information.

ABOUT PEMRYDI RTU®

PRODUCT INFORMATION & DOSING

REIMBURSEMENT & SUPPORT

RESOURCES

CONTACT US

The content on this site is intended for pharmacy directors and healthcare professionals. Patients may be interested in the patient reimbursement and support information found in the Reimbursement & Support and Resources sections.

© 2024 Amneal Pharmaceuticals LLC. All rights reserved.
PP-PEM-US-0003   12/24

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INDICATIONS

Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

PEMRYDI RTU® is indicated:

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ABOUT PEMRYDI RTU®

PRODUCT INFORMATION & DOSING

REIMBURSEMENT & SUPPORT

RESOURCES

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