FDA-filed SPL labeling · retrieved through openFDA

Pemetrexed Disodium

Pemetrexed disodium is a chemotherapy drug used intravenously to treat non-squamous non-small cell lung cancer (NSCLC) and malignant pleural mesothelioma.

Brand names Pemrydi RtuAlimta
Drug classes Folate Analog Metabolic Inhibitor
Rx Forms 2 Route Intravenous
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 22 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveDec 16, 2025
Clinical labels in scope 22
AvailabilityRx
Earliest approval/marketing year 2004
FDA-listed product records 146
Boxed warningNone found in compared labels
How we combine label and product data →
Pemetrexed Disodium at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Pemetrexed disodium is a chemotherapy given by IV infusion to treat non-squamous non-small cell lung cancer and malignant pleural mesothelioma. Taking folic acid and vitamin B12 supplements exactly as directed is critical — they meaningfully reduce serious side effects. Your care team will monitor your kidneys and blood counts closely throughout treatment.

📖 Pemetrexed Disodium: Patient Information Guide

A plain-language walkthrough of Pemetrexed Disodium — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

Pemetrexed disodium injection is a chemotherapy approved for two types of cancer. Available as Alimta, Pemrydi RTU, and generic pemetrexed products, it is used intravenously in the following situations:

  • Metastatic non-squamous NSCLC (initial treatment): In combination with pembrolizumab and platinum chemotherapy, for patients with no EGFR or ALK genetic mutations
  • Locally advanced or metastatic non-squamous NSCLC (initial treatment): In combination with cisplatin
  • Non-squamous NSCLC (maintenance therapy): As a single agent, after disease has not progressed through four cycles of platinum-based first-line chemotherapy
  • Recurrent metastatic non-squamous NSCLC (after prior chemotherapy): As a single agent
  • Malignant pleural mesothelioma (initial treatment): In combination with cisplatin, for disease that cannot be surgically removed or where surgery is not an option
  • Not approved for squamous cell non-small cell lung cancer
⚙️How it works

Pemetrexed disodium is a folate analog — meaning it mimics a B-vitamin (folate) that cells need to make DNA. It works by blocking three key enzymes (thymidylate synthase, dihydrofolate reductase, and GARFT) that cancer cells depend on to produce the raw materials for copying their DNA. Without those materials, cancer cells can't divide and grow. Once inside a cell, pemetrexed is converted to a more powerful form that gets retained in the cell, making its blocking effect stronger and longer-lasting.

💊How it's taken

Pemetrexed disodium is given as a short intravenous (IV) infusion — directly into a vein — on Day 1 of a 21-day treatment cycle, always administered by a healthcare professional in a clinical setting. The cycle repeats every 3 weeks, and the exact number of cycles depends on the treatment plan and how well the cancer responds.

  • Patients must start taking folic acid by mouth daily at least 7 days before the first infusion and continue until 21 days after the last dose
  • Vitamin B12 is given as an injection 1 week before the first infusion and then every 3 cycles
  • A steroid (dexamethasone) is taken by mouth twice daily the day before, the day of, and the day after each infusion
  • Kidney function is checked before each dose — treatment is held if kidney function falls too low
🤒Side effects — in detail

Side effects vary depending on whether pemetrexed is given alone or in combination with other drugs. The most commonly reported ones include:

  • Fatigue and weakness
  • Nausea, vomiting, constipation, or diarrhea
  • Loss of appetite
  • Low white blood cells (neutropenia — raises infection risk), low red blood cells (anemia), and low platelets (thrombocytopenia)
  • Rash
  • Cough or shortness of breath
  • Fever
  • Mouth sores (stomatitis/pharyngitis), especially when given with cisplatin

Serious reactions — including severe infections, kidney failure, dangerous skin blistering, and lung inflammation — can occur and require immediate medical attention. Regular blood tests help your team catch problems early.

⚠️Warnings & precautions
  • Bone marrow suppression (myelosuppression): Pemetrexed can severely lower blood cell counts, raising risk of serious infection, bleeding, and anemia. This risk is significantly higher in patients who skip folic acid and vitamin B12 supplementation. Blood counts are checked before every cycle.
  • Kidney failure: Pemetrexed can cause severe and sometimes fatal kidney damage. Kidney function is monitored regularly; treatment is stopped if function falls too low.
  • Serious skin reactions: Rare but life-threatening blistering and peeling skin conditions (including Stevens-Johnson syndrome and toxic epidermal necrolysis) can occur. Treatment is permanently stopped if these develop.
  • Lung inflammation (interstitial pneumonitis): New or worsening shortness of breath, cough, or fever should be reported immediately. Treatment is held and may be permanently stopped if pneumonitis is confirmed.
  • Radiation recall: Inflammation can flare in previously irradiated areas of the body — sometimes years later. Persistent redness or blistering in old radiation fields should be reported right away.
  • Fetal harm: Pemetrexed can cause serious birth defects. Effective contraception is required during and for 6 months (women) or 3 months (men) after treatment.
🔀What it interacts with

Pemetrexed disodium can be affected by certain other drugs that alter how it is cleared from the body:

  • Ibuprofen: Blocks a kidney transporter (OAT3) that helps clear pemetrexed, raising pemetrexed levels in the blood — particularly risky if your kidneys aren't working at full capacity. Avoid ibuprofen for 2 days before and after each infusion if you have reduced kidney function.
  • Other OAT3 inhibitors: Other drugs that block the same kidney transporter can also raise pemetrexed exposure and increase side effect risk — avoid when possible, or be monitored more closely if unavoidable.
  • Aspirin (low to moderate doses), naproxen, diclofenac, celecoxib: Not expected to significantly affect pemetrexed levels at clinically relevant concentrations, based on available data.
  • Cisplatin and platinum chemotherapy: These do not meaningfully change pemetrexed's pharmacokinetics and are intentionally combined as part of approved regimens under oncologist direction.
  • Folic acid and vitamin B12: These supplements do not alter pemetrexed's levels in the body, but they are essential for reducing serious toxicity.

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it
  • Kidney disease: Pemetrexed cannot be given if creatinine clearance (a measure of kidney function) is below 45 mL/min. Reduced kidney function also raises the risk of drug buildup and side effects.
  • Pregnancy: This drug causes fetal harm based on animal studies and its mechanism of action. Tell your doctor immediately if you are pregnant or become pregnant during treatment.
  • Contraception: Women of childbearing potential must use effective contraception during treatment and for at least 6 months after the last dose. Men with female partners of childbearing potential must use contraception during treatment and for 3 months after the last dose.
  • Breastfeeding: Do not breastfeed during treatment or for one week after the last dose — the potential risk to a nursing infant is unknown but serious.
  • Male fertility: Pemetrexed may impair fertility in men; it is unknown whether this is reversible. Discuss with your doctor before starting if this is a concern.
  • Children: Safety and effectiveness in pediatric patients have not been established.
  • Severe hypersensitivity: Anyone with a history of a severe allergic reaction to pemetrexed must not receive it again.
  • Vitamin supplementation history: Patients who have not started folic acid and vitamin B12 supplementation should not begin pemetrexed — the risk of life-threatening toxicity is substantially higher without these supplements.
🚑If you take too much

There is no approved antidote for a pemetrexed overdose. Based on animal data, leucovorin (a form of folate) may help reduce the toxic effects of too much pemetrexed. It is not known whether dialysis can remove pemetrexed from the body. If an overdose is suspected, seek emergency medical care immediately.

📡Pharmacodynamics — effects in the body

Pemetrexed works by lowering cancer cells' ability to replicate DNA — it does this by blocking folate-dependent enzymes the cells need to make DNA building blocks. In studies, it stopped the growth of mesothelioma cell lines and worked synergistically (better together) when combined with cisplatin. One measurable body effect is a drop in the absolute neutrophil count (ANC — the number of key infection-fighting white blood cells); the depth of this drop is linked to how much drug is in the system and whether folic acid and vitamin B12 supplementation was taken as directed.

🔬Pharmacokinetics — how your body processes it

After an IV infusion, pemetrexed distributes into about 16 liters of body fluid and is approximately 81% bound to proteins in the blood. It is not significantly broken down (metabolized) by the body. The drug is cleared primarily through the kidneys, with 70–90% of the dose excreted unchanged in the urine within the first 24 hours. In patients with normal kidney function, the half-life (the time for the body to clear half the drug) is about 3.5 hours. In patients with reduced kidney function, the drug clears more slowly and builds up to higher levels, which is why kidney function is carefully checked before every dose.

📦How to store it

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) .

📄 Written from Pemetrexed Disodium’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Pemetrexed Disodium — the kind of thing our pharmacy team would talk through with you at the counter.

Why do I have to take vitamins before and during my pemetrexed treatment?
The folic acid and vitamin B12 aren't just a nice-to-have — they're a required part of your treatment. Without them, pemetrexed is much more likely to cause severe drops in your blood cell counts and serious digestive side effects. Studies showed that patients who skipped these supplements had significantly higher rates of dangerous infections and other complications. Start the folic acid at least a week before your first infusion and don't stop until three weeks after your last dose. The B12 shot is given by your care team before you start and then every few cycles.
What side effects should I definitely call my doctor about right away?
The ones that can't wait are signs of infection — fever, chills, or feeling suddenly very unwell — because your white blood cell count may be dangerously low. Also call right away if you notice unusual bruising or bleeding, a sharp drop in urination or swelling (signs of kidney trouble), new or worsening shortness of breath or cough, severe skin blistering or peeling, or redness and pain in any area of your body that was previously treated with radiation. These are rare but serious, and catching them early makes a real difference.
Can I take ibuprofen or other pain relievers while I'm on pemetrexed?
It depends on your kidney function. If your kidneys aren't working at full capacity, ibuprofen can raise your pemetrexed levels — which increases the risk of serious side effects. Your care team will likely tell you to avoid ibuprofen for two days before and two days after each infusion if your kidney function is reduced. Low-to-moderate doses of aspirin and some other anti-inflammatories like naproxen and celecoxib are generally not expected to cause the same problem, but always check with your oncologist before taking any over-the-counter pain reliever.
Is pemetrexed safe to use if I'm planning to have children in the future?
This is really important to discuss with your doctor before treatment starts. Pemetrexed can harm a developing baby, so women need to use effective birth control during treatment and for at least 6 months after the last dose. Men with partners who could become pregnant need to use contraception during treatment and for 3 months after. There's also a possibility — though not fully studied — that pemetrexed may affect fertility in men. If having children is something you're thinking about, bring it up with your oncologist before your first infusion so you can plan accordingly.
How will I know if my body is responding well to pemetrexed?
Your oncology team will track your response through regular imaging (like CT scans) and blood tests throughout your treatment. Blood tests before every cycle check your kidney function and blood cell counts — if these fall too low, your team may delay or adjust your treatment. The goal is to keep the cancer from progressing while keeping side effects manageable. Be open with your team about how you're feeling between cycles so they can fine-tune your care.
Why does pemetrexed work for some lung cancers but not others?
Pemetrexed is specifically approved for non-squamous non-small cell lung cancer — a category that includes adenocarcinoma and large cell carcinoma. Clinical studies showed it was not effective for the squamous cell type of NSCLC, so it's not approved for that subtype. Your oncologist will have confirmed which type of lung cancer you have before recommending pemetrexed. For mesothelioma, pemetrexed combined with cisplatin is an established first-line option for disease that can't be surgically removed.
Is Pemetrexed Disodium available over the counter?
Pemetrexed Disodium is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Pemetrexed Disodium first available?
Pemetrexed Disodium has been available in the United States since at least 2004, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Pemetrexed Disodium?
Pemetrexed Disodium is supplied by 37 manufacturers listed in the FDA NDC Directory, including Meitheal Pharmaceuticals Inc., BluePoint Laboratories, Fresenius Kabi USA, LLC.

💬 Answers drafted from Pemetrexed Disodium’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Pemetrexed Disodium comes

Pemetrexed Disodium is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Injection

By injection · Into a vein
Brands Alimta Pemrydi Rtu
How this form is used
What it may be used for
  • Alimta (injection) is indicated for initial treatment of metastatic non-squamous NSCLC with pembrolizumab and platinum chemotherapy, with cisplatin alone, and as maintenance or second-line single-agent therapy
  • Pemrydi RTU (injection) is indicated for initial treatment of metastatic non-squamous NSCLC with pembrolizumab and platinum chemotherapy, with cisplatin, and as single-agent maintenance or post-chemotherapy treatment
  • Pemetrexed and Pemetrexed disodium injections are indicated for non-squamous NSCLC across multiple settings and for malignant pleural mesothelioma in combination with cisplatin
  • All injection products are indicated for initial treatment of unresectable malignant pleural mesothelioma in combination with cisplatin
Important instructions
  • Alimta, Pemrydi RTU, and pemetrexed injections are all administered as an intravenous infusion over approximately 10 minutes on Day 1 of each 21-day cycle
  • Before each infusion, patients must have taken daily oral folic acid starting at least 7 days before the first dose, continuing until 21 days after the last dose
  • Vitamin B12 is injected intramuscularly 1 week before the first infusion and then every 3 cycles throughout treatment
  • Dexamethasone is taken by mouth twice daily the day before, the day of, and the day after each infusion to reduce skin reactions
Available strengths 12 strengths
Show 6 more strengths Show fewer strengths
124 FDA-listed product records

📊 Pemetrexed Disodium across the U.S. market

How Pemetrexed Disodium appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

2
Dose forms
37
Manufacturers
4
Brand names
146
FDA-listed product records
2004
First marketed

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (20) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Meitheal Pharmaceuticals Inc.14%
BluePoint Laboratories10%
Fresenius Kabi USA, LLC8%
Apotex Corp6%
Sandoz Inc.6%
Eli Lilly and Company5%
Other makers51%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Pemetrexed Disodium is used

A general measure of how commonly Pemetrexed Disodium is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Pemetrexed Disodium is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

6,448
Medicaid prescriptions filled (Q1–Q4 2025)
$5M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Pemetrexed Disodium prescribed? Of the 1,596 medications we measure, Pemetrexed Disodium ranks #1,008 by Medicaid prescriptions — more than 37% of them.

Where Pemetrexed Disodium ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Pemetrexed Disodium, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 19 of 94 listed Pemetrexed Disodium NDCs with Medicaid activity.

🔍 Compare Pemetrexed Disodium products

A representative set of FDA-listed product records for Pemetrexed Disodium — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 146 of 146 products — FDA National Drug Code Directory. See every product, package size and price: browse all 146 Pemetrexed Disodium NDCs →

🏷️ Sold under these brand names

Pemrydi Rtu Alimta

🏭 Manufacturers & labelers

Meitheal Pharmaceuticals Inc. 20 BluePoint Laboratories 14 Fresenius Kabi USA, LLC 12 Apotex Corp 9 Sandoz Inc. 9 Eli Lilly and Company 8 Amneal Pharmaceuticals LLC 6 Shilpa Medicare Limited 6 Jiangsu Hansoh Pharmaceutical Group Co., Ltd. 4 Waverley Pharma Inc 4 Lilly France 4 Ingenus Pharmaceuticals, LLC 4 Athenex Pharmaceutical Division, LLC. 4 Eli Lilly Kinsale Limited 4 Zydus Pharmaceuticals USA Inc. 3 Zydus Lifesciences Limited 3 Dr. Reddys Laboratories Inc 3 Sagent Pharmaceuticals 2 Wuhan Calmland Pharmaceuticals Co., Ltd. 2 Somerset Therapeutics LLC 2 BSP Pharmaceuticals S.p.A. 2 Qilu Pharmaceutical Co., Ltd. 2 NorthStar RxLLC 2 MSN Laboratories Private Limited 2

…and 13 more on the FDA NDC directory.

RxNorm drug class

Pemetrexed Disodium belongs to the Folate Analog Metabolic Inhibitor class.

Pharmacologic class Folate Analog Metabolic Inhibitor
Drug family (ATC) Folic acid analogues
How it works Folic Acid Metabolism Inhibitors

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Dec 16, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Pemetrexed Disodium.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Pemetrexed Disodium after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
22
NDC products indexed
146
Distinct labelers/manufacturers represented
37
Linked representative label
Sandoz Inc.
Linked label effective
Dec 16, 2025
Composite sections available
23
Linked SPL Set ID
7ac04ab7-7f8c-46ce-ab56-a7a08cd02ab3
Linked SPL Document ID
764ab64b-c642-4314-83a9-efee79fe83a3
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 22 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Sandoz Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.