Ziv-aflibercept Injection
Ziv-aflibercept Injection (Zaltrap) is an intravenous cancer medicine used with FOLFIRI chemotherapy to treat metastatic colorectal cancer that has resisted or progressed after an oxaliplatin-containing regimen.
🧬 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 1 clinical label set 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 →
Zaltrap (ziv-aflibercept) is an IV cancer medicine added to FOLFIRI chemotherapy for metastatic colorectal cancer (cancer that has spread) that has kept growing despite an oxaliplatin-containing regimen. It works like a sponge, soaking up the growth signals tumors use to build new blood vessels, and has been a specialist second-line option since about 2012, available only as the brand. The combination is tough, and diarrhea, mouth sores, tiredness, nosebleeds and rising blood pressure are what most people notice, which is why blood pressure is checked every two weeks. Bleeding and holes in the bowel are the risks to take most seriously, so black or bloody stools, coughing up blood or severe belly pain mean calling your care team right away.
Clinical pearls
- Zaltrap must be stopped at least 4 weeks before elective surgery, so tell any surgeon early, since it also slows wound healing.
- Diarrhea can become severe, especially in people 65 and older, so get an anti-diarrhea plan from your oncology team before starting.
- Foamy urine or new swelling can signal protein loss through the kidneys, which is why your urine is checked regularly.
- Use effective contraception during treatment and for 3 months after, and avoid breastfeeding until 1 month after the last dose.
Patient information guide A plain-language walkthrough of Ziv-aflibercept Injection, written from its FDA label.
What Ziv-aflibercept Injection is used for
▾
Ziv-aflibercept Injection is used for one cancer indication.
- Zaltrap, given with FOLFIRI, treats metastatic colorectal cancer that is resistant to or has progressed after an oxaliplatin-containing regimen.
How Ziv-aflibercept Injection works
▾
Zaltrap is a soluble receptor that binds VEGF-A, VEGF-B and PlGF. These are signals that help new blood vessels grow and make vessels leaky. By blocking them, Zaltrap can reduce new blood vessel growth.
In animals, it slowed endothelial cell growth and the growth of colon tumors.
Ziv-aflibercept Injection dosage
▾
Zaltrap is given by IV infusion in a clinic over about 1 hour, every 2 weeks, along with FOLFIRI. It is given first on treatment days. It is never given as an IV push.
- Your dose is based on your body weight.
- Your team may pause or lower the dose for high blood pressure or protein in the urine.
- Food does not apply, since it is given by IV.
- If you miss an appointment, contact your care team to reschedule.
Dosing details from the FDA-approved label
From the Ziv-aflibercept Injection prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Recommended dose and schedule (in combination with FOLFIRI)
- 4 mg per kg of actual body weight as an intravenous infusion over 1 hour every two weeks in combination with FOLFIRI until disease progression or unacceptable toxicity
- Administer ZALTRAP prior to any component of the FOLFIRI regimen on the day of treatment
- Do not administer as an intravenous push or bolus
- Uncontrolled hypertension
- Temporarily suspend ZALTRAP until controlled
- Upon resumption, permanently reduce the dose to 2 mg per kg
- Proteinuria of 2 grams per 24 hours or more
- Suspend ZALTRAP and resume when proteinuria is less than 2 grams per 24 hours
- Recurrent proteinuria
- Suspend ZALTRAP until proteinuria is less than 2 grams per 24 hours and then permanently reduce the dose to 2 mg per kg
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION 4 mg per kg as an intravenous infusion over 1 hour every 2 weeks. ( 2.1 , 2.3 ) Do not administer as an intravenous push or bolus. ( 2.3 ) 2.1 Recommended Dose and Schedule The recommended dosage of ZALTRAP is 4 mg per kg of actual body weight as an intravenous infusion over 1 hour every two weeks in combination with FOLFIRI until disease progression or unacceptable toxicity. Administer ZALTRAP prior to any component of the FOLFIRI regimen on the day of treatment. Refer to prescribing information for irinotecan, fluorouracil, and leucovorin for the recommended dosage and dosage modifications for these drugs. 2.2 Dosage Modifications for Adverse Reactions Discontinue ZALTRAP for: Severe hemorrhage [see Warnings and Precautions (5.1) ] Gastrointestinal perforation [see Warnings and Precautions (5.2) ] Impaired wound healing [see Warnings and Precautions (5.3) ] Fistula formation [see Warnings and Precautions (5.4) ] Hypertensive crisis or hypertensive encephalopathy [see Warnings and Precautions (5.5) ] Arterial thromboembolic events (ATE) [see Warnings and Precautions (5.6) ] Nephrotic syndrome or thrombotic microangiopathy (TMA) [see Warnings and Precautions (5.7) ] Reversible posterior leukoencephalopathy syndrome (RPLS) [see Warnings and Precautions (5.10) ] Temporarily suspend ZALTRAP: At least 4 weeks prior to elective surgery [see Warnings and Precautions (5.3) ]. For uncontrolled hypertension until controlled. Upon resumption, permanently reduce the ZALTRAP dose to 2 mg per kg [see Warnings and Precautions (5.5) ] . For proteinuria of 2 grams per 24 hours or more. Resume when proteinuria is less than 2 grams per 24 hours. For recurrent proteinuria, suspend ZALTRAP until proteinuria is less than 2 grams per 24 hours and then permanently reduce the ZALTRAP dose to 2 mg per kg [see Warnings and Precautions (5.7) ] . 2.3 Preparation and Administration Preparation Inspect vials visually prior to use. ZALTRAP is a clear, colorless to pale yellow solution. Do not use vial if the solution is discolored or cloudy or if the solution contains particles. Withdraw the prescribed dose of ZALTRAP and dilute in 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP to achieve a final concentration of 0.6 mg/mL to 8 mg/mL. Do not re-enter the vial after the initial puncture. Discard any unused portion left in the vial.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Ziv-aflibercept Injection side effects
▾
Common side effects seen with Zaltrap plus FOLFIRI include:
Common side effects
- Low white blood cell counts (leukopenia, neutropenia)
- Diarrhea
- Protein in the urine (proteinuria)
- Mouth sores (stomatitis)
- Tiredness (fatigue)
- High blood pressure
- Decreased appetite and weight loss
- Nosebleeds and headache
- Low white blood cells and platelets
- Nosebleeds, hoarse voice, abdominal pain and headache
- Raised liver enzymes (AST, ALT) and creatinine on blood tests
When to get medical help
- Call your care team right away for any serious bleeding, such as black or bloody stools, blood in urine, coughing up blood, or a severe headache.
- Get help for severe belly pain, which could signal a hole in the stomach or bowel (gastrointestinal perforation).
- Tell your team about very high blood pressure, or a severe headache with confusion or vision changes.
- Seek urgent care for signs of a stroke, mini-stroke or angina (chest pain), such as weakness, trouble speaking, or chest pain.
- Report severe or ongoing diarrhea, or signs of dehydration.
- Report fever or signs of infection, since low neutrophil counts can lead to serious infections.
- Report swelling, foamy urine, or a wound that is not healing.
- Report any abnormal opening (fistula) between body areas.
Serious reactions include severe bleeding, bowel perforation, blood clots, severe diarrhea and infections. Report these right away.
Ziv-aflibercept Injection warnings and precautions
▾
- Bleeding: can be severe or fatal, including in the gut, brain and lungs.
- Bowel perforation and fistulas: treatment is stopped if they occur.
- Wound healing: hold at least 4 weeks before elective surgery and after major surgery until healed.
- High blood pressure: checked every two weeks. Treatment may be paused or the dose lowered.
- Arterial clots: including stroke-like events and angina.
- Kidney effects: protein in the urine, nephrotic syndrome, thrombotic microangiopathy.
- Low neutrophils: blood counts checked before each cycle.
- Diarrhea and dehydration: more common in adults 65 and older.
- RPLS: a rare brain condition; Zaltrap is stopped.
- Fetal harm: can harm an unborn baby.
Ziv-aflibercept Injection interactions
▾
The label reports few interaction concerns.
- No dedicated interaction studies were done for Zaltrap.
- No important interactions were found with irinotecan/SN-38 or fluorouracil, which are part of FOLFIRI.
- It is not mixed with other drugs in the same IV bag or line.
Interactions listed in the FDA-approved label
From the Ziv-aflibercept Injection prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Irinotecan/SN-38: No clinically important pharmacokinetic interactions were found between ziv-aflibercept and irinotecan/SN-38.
- Fluorouracil: No clinically important pharmacokinetic interactions were found between ziv-aflibercept and fluorouracil.
Read the label’s full interactions text
7 DRUG INTERACTIONS No dedicated drug-drug interaction studies have been conducted for ZALTRAP. No clinically important pharmacokinetic interactions were found between ziv-aflibercept and irinotecan/SN-38 or fluorouracil [see Clinical Pharmacology (12.3) ] .
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Ziv-aflibercept Injection
▾
- Pregnancy: it can cause fetal harm. A pregnancy test is checked first, and effective contraception is advised during treatment and for 3 months after the last dose.
- Breastfeeding: avoid during treatment and for 1 month after the last dose.
- Fertility: it may impair fertility in women and men.
- Children: safety and effectiveness have not been established.
- Older adults (65+): closer monitoring for diarrhea and dehydration.
- Planned surgery: tell your team, since Zaltrap must be held beforehand.
- Heart failure: no trial experience in NYHA class III or IV.
- Severe liver impairment: not studied.
What Ziv-aflibercept Injection does in the body
▾
Zaltrap blocks VEGF-A, VEGF-B and PlGF, which reduces new blood vessel growth and vessel leakiness. In a study of 87 patients with solid tumors, no large changes in the heart's QT interval were seen. A small increase of less than 10 ms could not be ruled out.
How your body processes Ziv-aflibercept Injection
▾
Steady-state levels of free ziv-aflibercept were reached by the second dose. The half-life is about 6 days (range 4 to 7 days) with dosing every two weeks. Age, race and sex did not have a clinically important effect on exposure. People weighing 100 kg or more had about 29% higher exposure.
Mild and moderate liver impairment did not affect clearance. There are no data for severe liver impairment.
How to store Ziv-aflibercept Injection
▾
Store ZALTRAP vials in a refrigerator at 2°C to 8°C (36°F to 46°F). protect from light.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Ziv-aflibercept Injection: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Ziv-aflibercept Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What is Zaltrap used for?
▾
How will I get it?
▾
What side effects should I expect?
▾
When should I call my care team right away?
▾
Do I need to worry about surgery?
▾
Is it safe in pregnancy?
▾
Is Ziv-aflibercept Injection available over the counter?
▾
When was Ziv-aflibercept Injection first available?
▾
Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Ziv-aflibercept Injection on HelloPharmacist
Ziv-aflibercept Injection forms and strengths (how it comes)
Ziv-aflibercept Injection is available in 1 form. 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.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Ziv-aflibercept Injection inactive ingredients by manufacturer.
Injection
How this form is used
- Zaltrap is used with FOLFIRI for metastatic colorectal cancer resistant to or progressed after an oxaliplatin-containing regimen.
- Zaltrap is diluted and given as an IV infusion over 1 hour, not as an IV push or bolus.
- Zaltrap is given every 2 weeks before any part of FOLFIRI.
- Zaltrap is infused through a 0.2-micron polyethersulfone filter and not mixed with other drugs in the same bag or line.
Ziv-aflibercept Injection on the U.S. market: products, makers and brands
How Ziv-aflibercept Injection 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.
1 company lists 2 Ziv-aflibercept Injection product records with the FDA, mostly as injection; the earliest marketing or approval year on record is 2012. Brand names on the directory include Zaltrap; the rest are generics.
Compare Ziv-aflibercept Injection products
A representative set of FDA-listed product records for Ziv-aflibercept Injection — 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.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 100 mg/4 mL | Intravenous | sanofi-aventis U.S. LLC | BLA | View NDC → |
| 200 mg/8 mL | Intravenous | sanofi-aventis U.S. LLC | BLA | View NDC → |
Showing 2 of 2 products — FDA National Drug Code Directory. See every product, package size and price: browse all 2 Ziv-aflibercept Injection NDCs →
Ziv-aflibercept Injection side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Ziv-aflibercept Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Ziv-aflibercept Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Ziv-aflibercept Injection FDA approval history
How Ziv-aflibercept Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Ziv-aflibercept Injection recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Ziv-aflibercept recalls since July 2021.
✅No Ziv-aflibercept recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
Ziv-aflibercept Injection supply and shortage status
Whether Ziv-aflibercept Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Ziv-aflibercept Injection brand names
Ziv-aflibercept Injection is sold under one brand name in the FDA directory — Zaltrap. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Ziv-aflibercept Injection: manufacturers and labelers
One company lists Ziv-aflibercept Injection products with the FDA. By number of product records, the largest are sanofi-aventis U.S. LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Ziv-aflibercept Injection drug class (RxNorm)
Ziv-aflibercept Injection belongs to the Vascular Endothelial Growth Factor Inhibitor class.
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.
Sources for this Ziv-aflibercept Injection page
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.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. sanofi-aventis U.S. LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →