PEMRYDI

PEMRYDI RTU® (pemetrexed injection) from Amneal Biosciences

The first and only ready-to-use presentation of pemetrexed1-3

  • No reconstitution or dilution needed1
  • Stable at room temperature in original packaging1
  • Withdraw the calculated dose from the vial(s) and transfer to an empty IV bag1*
  • 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

*Discard the vial with any unused portion of drug.1
†Controlled room temperature is defined as 20°C to 25°C (68°F to 77°F).1

Use the unique HCPCS code J9324 when billing for PEMRYDI RTU®.4

Use the unique HCPCS code
J9324 when billing for PEMRYDI RTU®.4

PEMRYDI RTU® has the same indications as other pemetrexed injection products1-3

The FDA has approved PEMRYDI RTU® for the indications listed below:

Non-squamous non-small cell lung cancer (NSCLC)

PEMRYDI RTU® is indicated1:

  • 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 the treatment of patients with squamous cell NSCLC.

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

PEMRYDI RTU® is the first and only ready-to-use presentation of pemetrexed1-3

PEMRYDI RTU®

(pemetrexed injection)1

Pemfexy®

(pemetrexed injection)2

Alimta®

(pemetrexed for injection)3

Does not require

RECONSTITUTION

Does not require

DILUTION

STABLE AT ROOM TEMPERATURE

in original packaging*

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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

PEMRYDI RTU® was approved via the FDA's 505(b)(2) regulatory pathway

The first and only ready-to-use presentation of Alimta®, PEMRYDI RTU® was approved via the 505(b)(2) regulatory pathway.1-3 Products approved via the 505(b)(2) regulatory pathway5-8:

  • Contain full safety and effectiveness reports, based at least in part on the originator product’s data
  • Allow for changes in product characteristics that may support operational efficiency, such as ready-to-use formulations or other differences in dosage form, strength, or route of administration

As with all FDA-approved medicines, products approved under the 505(b)(2) pathway undergo rigorous evaluation to assess for efficacy, safety, and quality.1,5,9

Most 505(b)(2)-approved products have their own unique HCPCS code for product-specific reimbursement and greater cost transparency.4,10,11
The unique code for PEMRYDI RTU® is J9324.4

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

ALK, anaplastic lymphoma kinase; EGFR, epidermal growth factor receptor; HCPCS, Healthcare Common Procedure Coding System; IV, intravenous; NSCLC, non-small cell lung cancer.

PEMRYDI RTU® is a registered trademark of Amneal Pharmaceuticals LLC.
Pemfexy® is a registered trademark of Eagle Pharmaceuticals, Inc.
Alimta® is a registered trademark owned by or licensed to Eli Lilly and Company, its subsidiaries, or affiliates.

References: 1. PEMRYDI RTU. Prescribing information. Amneal Pharmaceuticals LLC; 2024. 2. Pemfexy. Prescribing information. Eagle Pharmaceuticals, Inc.; 2022. 3. Alimta. Prescribing information. Eli Lilly and Company; 2004. 4. CMS. First quarter, 2024 HCPCS quarterly update. Updated March 21, 2024. https://www.cms.gov/medicare/coding-billing/healthcare-common-procedure-system/quarterly-update 5. Lal R. Updated September 19, 2019. https://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/abbreviated-approval-pathways-drug-product-505b2-or-anda 6. GRP. July 2017. https://globalregulatorypartners.com/white_papers/overview-of-fda-505b2-regulatory-pathway/ 7. Goldstein B. Overview of the 505(b)(2) regulatory pathway for new drug applications. Food and Drug Administration. Accessed March 14, 2024. https://www.fda.gov/media/156350/download 8. Freije I, Lamouche S, Tanguay M. Review of drugs approved via the 505(b)(2) pathway: uncovering drug development trends and regulatory requirements. Ther Innov Regul Sci. 2020;54(1):128-138. 9. Meadows M. Promoting safe and effective drugs for 100 years. FDA Consum. 2006;40(1):14-20. 10. Avalere. February 3, 2023. https://avalere.com/insights/505b2-changes-that-generic-manufacturers-should-know 11. MMIT. January 12, 2024. https://www.mmitnetwork.com/thought-leadership/new-hcpcs-codes-for-generics-what-payers-and-manufacturers-should-know-to-ensure-accurate-reimbursement/

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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