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ZALTRAP

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Overview

What is ZALTRAP?

Ziv-aflibercept is a recombinant fusion protein consisting of Vascular Endothelial Growth Factor (VEGF)-binding portions from the extracellular domains of human VEGF Receptors 1 and 2 fused to the Fc portion of the human IgG1. Ziv-aflibercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) K-1 mammalian expression system. Ziv-aflibercept is a dimeric glycoprotein with a protein molecular weight of 97 kilodaltons (kDa) and contains glycosylation, constituting an additional 15% of the total molecular mass, resulting in a total molecular weight of 115 kDa.

ZALTRAP is a sterile, clear, colorless to pale yellow, non-pyrogenic, preservative-free, solution for administration by intravenous infusion. ZALTRAP is supplied in single-use vials of 100 mg per 4 ml and 200 mg per 8 ml formulated as 25 mg/mL ziv-aflibercept in polysorbate 20 (0.1%), sodium chloride (100 mM), sodium citrate (5 mM), sodium phosphate (5 mM), and sucrose (20%), in Water for Injection USP, at a pH of 6.2.



What does ZALTRAP look like?



What are the available doses of ZALTRAP?

ZALTRAP is available as:

What should I talk to my health care provider before I take ZALTRAP?

How should I use ZALTRAP?

ZALTRAP, in combination with 5-fluorouracil, leucovorin, irinotecan-(FOLFIRI), is indicated for patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-containing regimen [].

Administer ZALTRAP 4 mg per kg as an intravenous (IV) infusion over 1 hour every two weeks. Administer ZALTRAP prior to any component of the FOLFIRI regimen on the day of treatment [].

Continue ZALTRAP until disease progression or unacceptable toxicity.


What interacts with ZALTRAP?

Sorry No Records found


What are the warnings of ZALTRAP?

Sorry No Records found


What are the precautions of ZALTRAP?

Sorry No Records found


What are the side effects of ZALTRAP?

Sorry No records found


What should I look out for while using ZALTRAP?

None

Hemorrhage: Severe and sometimes fatal hemorrhage, including gastrointestinal (GI) hemorrhage, has been reported in the patients who have received ZALTRAP in combination with FOLFIRI. Monitor patients for signs and symptoms of GI bleeding and other severe bleeding. Do not administer ZALTRAP to patients with severe hemorrhage [].

Gastrointestinal Perforation: Gastrointestinal (GI) perforation including fatal GI perforation can occur in patients receiving ZALTRAP. Discontinue ZALTRAP therapy in patients who experience GI perforation [].

Compromised Wound Healing: Severe compromised wound healing can occur in patients receiving ZALTRAP/FOLFIRI. Discontinue ZALTRAP in patients with compromised wound healing. Suspend ZALTRAP for at least 4 weeks prior to elective surgery, and do not resume ZALTRAP for at least 4 weeks following major surgery and until the surgical wound is fully healed [].


What might happen if I take too much ZALTRAP?

There have been no cases of overdose reported with ZALTRAP. There is no information on the safety of ZALTRAP given at doses exceeding 7 mg per kg every 2 weeks or 9 mg per kg every 3 weeks.


How should I store and handle ZALTRAP?

Store ZALTRAP vials in a refrigerator at 2 to 8°C (36 to 46°F). Keep the vials in the original outer carton to protect from light.Fenofibrate tablets, USP 54 mg are white to off-white, oval-shaped, biconvex, film-coated tablets, debossed with “” on one side and plain on the other side. They are supplied as follows.NDC 63304-900-03 Bottles of 10NDC 63304-900-90 Bottles of 90NDC 63304-900-10 Bottles of 1000Fenofibrate tablets, USP 160 mg are white to off-white, oval-shaped, biconvex, film-coated tablets, debossed with “” on one side and plain on the other side. They are supplied as follows. NDC 63304-901-03 Bottles of 10NDC 63304-901-90 Bottles of 90NDC 63304-901-10 Bottles of 1000Store at 20° - 25° C (68° - 77° F) [see USP Controlled Room Temperature]. Keep out of the reach of children. Protect from moisture.You may report side effects to FDA at .Fenofibrate tablets, USP 54 mg are white to off-white, oval-shaped, biconvex, film-coated tablets, debossed with “” on one side and plain on the other side. They are supplied as follows.NDC 63304-900-03 Bottles of 10NDC 63304-900-90 Bottles of 90NDC 63304-900-10 Bottles of 1000Fenofibrate tablets, USP 160 mg are white to off-white, oval-shaped, biconvex, film-coated tablets, debossed with “” on one side and plain on the other side. They are supplied as follows. NDC 63304-901-03 Bottles of 10NDC 63304-901-90 Bottles of 90NDC 63304-901-10 Bottles of 1000Store at 20° - 25° C (68° - 77° F) [see USP Controlled Room Temperature]. Keep out of the reach of children. Protect from moisture.You may report side effects to FDA at .Fenofibrate tablets, USP 54 mg are white to off-white, oval-shaped, biconvex, film-coated tablets, debossed with “” on one side and plain on the other side. They are supplied as follows.NDC 63304-900-03 Bottles of 10NDC 63304-900-90 Bottles of 90NDC 63304-900-10 Bottles of 1000Fenofibrate tablets, USP 160 mg are white to off-white, oval-shaped, biconvex, film-coated tablets, debossed with “” on one side and plain on the other side. They are supplied as follows. NDC 63304-901-03 Bottles of 10NDC 63304-901-90 Bottles of 90NDC 63304-901-10 Bottles of 1000Store at 20° - 25° C (68° - 77° F) [see USP Controlled Room Temperature]. Keep out of the reach of children. Protect from moisture.You may report side effects to FDA at .Fenofibrate tablets, USP 54 mg are white to off-white, oval-shaped, biconvex, film-coated tablets, debossed with “” on one side and plain on the other side. They are supplied as follows.NDC 63304-900-03 Bottles of 10NDC 63304-900-90 Bottles of 90NDC 63304-900-10 Bottles of 1000Fenofibrate tablets, USP 160 mg are white to off-white, oval-shaped, biconvex, film-coated tablets, debossed with “” on one side and plain on the other side. They are supplied as follows. NDC 63304-901-03 Bottles of 10NDC 63304-901-90 Bottles of 90NDC 63304-901-10 Bottles of 1000Store at 20° - 25° C (68° - 77° F) [see USP Controlled Room Temperature]. Keep out of the reach of children. Protect from moisture.You may report side effects to FDA at .Fenofibrate tablets, USP 54 mg are white to off-white, oval-shaped, biconvex, film-coated tablets, debossed with “” on one side and plain on the other side. They are supplied as follows.NDC 63304-900-03 Bottles of 10NDC 63304-900-90 Bottles of 90NDC 63304-900-10 Bottles of 1000Fenofibrate tablets, USP 160 mg are white to off-white, oval-shaped, biconvex, film-coated tablets, debossed with “” on one side and plain on the other side. They are supplied as follows. NDC 63304-901-03 Bottles of 10NDC 63304-901-90 Bottles of 90NDC 63304-901-10 Bottles of 1000Store at 20° - 25° C (68° - 77° F) [see USP Controlled Room Temperature]. Keep out of the reach of children. Protect from moisture.You may report side effects to FDA at .Fenofibrate tablets, USP 54 mg are white to off-white, oval-shaped, biconvex, film-coated tablets, debossed with “” on one side and plain on the other side. They are supplied as follows.NDC 63304-900-03 Bottles of 10NDC 63304-900-90 Bottles of 90NDC 63304-900-10 Bottles of 1000Fenofibrate tablets, USP 160 mg are white to off-white, oval-shaped, biconvex, film-coated tablets, debossed with “” on one side and plain on the other side. They are supplied as follows. NDC 63304-901-03 Bottles of 10NDC 63304-901-90 Bottles of 90NDC 63304-901-10 Bottles of 1000Store at 20° - 25° C (68° - 77° F) [see USP Controlled Room Temperature]. Keep out of the reach of children. Protect from moisture.You may report side effects to FDA at .Fenofibrate tablets, USP 54 mg are white to off-white, oval-shaped, biconvex, film-coated tablets, debossed with “” on one side and plain on the other side. They are supplied as follows.NDC 63304-900-03 Bottles of 10NDC 63304-900-90 Bottles of 90NDC 63304-900-10 Bottles of 1000Fenofibrate tablets, USP 160 mg are white to off-white, oval-shaped, biconvex, film-coated tablets, debossed with “” on one side and plain on the other side. They are supplied as follows. NDC 63304-901-03 Bottles of 10NDC 63304-901-90 Bottles of 90NDC 63304-901-10 Bottles of 1000Store at 20° - 25° C (68° - 77° F) [see USP Controlled Room Temperature]. Keep out of the reach of children. Protect from moisture.You may report side effects to FDA at .Fenofibrate tablets, USP 54 mg are white to off-white, oval-shaped, biconvex, film-coated tablets, debossed with “” on one side and plain on the other side. They are supplied as follows.NDC 63304-900-03 Bottles of 10NDC 63304-900-90 Bottles of 90NDC 63304-900-10 Bottles of 1000Fenofibrate tablets, USP 160 mg are white to off-white, oval-shaped, biconvex, film-coated tablets, debossed with “” on one side and plain on the other side. They are supplied as follows. NDC 63304-901-03 Bottles of 10NDC 63304-901-90 Bottles of 90NDC 63304-901-10 Bottles of 1000Store at 20° - 25° C (68° - 77° F) [see USP Controlled Room Temperature]. Keep out of the reach of children. Protect from moisture.You may report side effects to FDA at .Fenofibrate tablets, USP 54 mg are white to off-white, oval-shaped, biconvex, film-coated tablets, debossed with “” on one side and plain on the other side. They are supplied as follows.NDC 63304-900-03 Bottles of 10NDC 63304-900-90 Bottles of 90NDC 63304-900-10 Bottles of 1000Fenofibrate tablets, USP 160 mg are white to off-white, oval-shaped, biconvex, film-coated tablets, debossed with “” on one side and plain on the other side. They are supplied as follows. NDC 63304-901-03 Bottles of 10NDC 63304-901-90 Bottles of 90NDC 63304-901-10 Bottles of 1000Store at 20° - 25° C (68° - 77° F) [see USP Controlled Room Temperature]. Keep out of the reach of children. Protect from moisture.You may report side effects to FDA at .Fenofibrate tablets, USP 54 mg are white to off-white, oval-shaped, biconvex, film-coated tablets, debossed with “” on one side and plain on the other side. They are supplied as follows.NDC 63304-900-03 Bottles of 10NDC 63304-900-90 Bottles of 90NDC 63304-900-10 Bottles of 1000Fenofibrate tablets, USP 160 mg are white to off-white, oval-shaped, biconvex, film-coated tablets, debossed with “” on one side and plain on the other side. They are supplied as follows. NDC 63304-901-03 Bottles of 10NDC 63304-901-90 Bottles of 90NDC 63304-901-10 Bottles of 1000Store at 20° - 25° C (68° - 77° F) [see USP Controlled Room Temperature]. Keep out of the reach of children. Protect from moisture.You may report side effects to FDA at .


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Ziv-aflibercept acts as a soluble receptor that binds to human VEGF-A (equilibrium dissociation constant Kof 0.5 pM for VEGF-A and 0.36 pM for VEGF-A), to human VEGF-B (K of 1.92 pM), and to human PlGF (K of 39 pM for PlGF-2). By binding to these endogenous ligands, ziv-aflibercept can inhibit the binding and activation of their cognate receptors. This inhibition can result in decreased neovascularization and decreased vascular permeability.

In animals, ziv-aflibercept was shown to inhibit the proliferation of endothelial cells, thereby inhibiting the growth of new blood vessels. Ziv-aflibercept inhibited the growth of xenotransplanted colon tumors in mice.

Non-Clinical Toxicology
None

Hemorrhage: Severe and sometimes fatal hemorrhage, including gastrointestinal (GI) hemorrhage, has been reported in the patients who have received ZALTRAP in combination with FOLFIRI. Monitor patients for signs and symptoms of GI bleeding and other severe bleeding. Do not administer ZALTRAP to patients with severe hemorrhage [].

Gastrointestinal Perforation: Gastrointestinal (GI) perforation including fatal GI perforation can occur in patients receiving ZALTRAP. Discontinue ZALTRAP therapy in patients who experience GI perforation [].

Compromised Wound Healing: Severe compromised wound healing can occur in patients receiving ZALTRAP/FOLFIRI. Discontinue ZALTRAP in patients with compromised wound healing. Suspend ZALTRAP for at least 4 weeks prior to elective surgery, and do not resume ZALTRAP for at least 4 weeks following major surgery and until the surgical wound is fully healed [].

Oral Anticoagulants: CAUTION SHOULD BE EXERCISED WHEN COUMARIN ANTICOAGULANTS ARE GIVEN IN CONJUNCTION WITH FENOFIBRATE TABLETS. THE DOSAGE OF THE ANTICOAGULANTS SHOULD BE REDUCED TO MAINTAIN THE PROTHROMBIN TIME/INR AT THE DESIRED LEVEL TO PREVENT BLEEDING COMPLICATIONS. FREQUENT PROTHROMBIN TIME/INR DETERMINATIONS ARE ADVISABLE UNTIL IT HAS BEEN DEFINITELY DETERMINED THAT THE PROTHROMBIN TIME/INR HAS STABILIZED.





Resins:

Cyclosporine:

Patients treated with ZALTRAP have an increased risk of hemorrhage, including severe and sometimes fatal hemorrhagic events. In patients with mCRC, bleeding/hemorrhage (all grades) were reported in 38% of patients treated with ZALTRAP/FOLFIRI compared to 19% of patients treated with placebo/FOLFIRI. Grade 3–4 hemorrhagic events, including gastrointestinal hemorrhage, hematuria, and post-procedural hemorrhage, were reported in 3% of patients receiving ZALTRAP/FOLFIRI compared with 1% of patients receiving placebo/FOLFIRI. Severe intracranial hemorrhage and pulmonary hemorrhage/hemoptysis including fatal events have also occurred in patients receiving ZALTRAP.

Monitor patients for signs and symptoms of bleeding. Do not initiate ZALTRAP in patients with severe hemorrhage. Discontinue ZALTRAP in patients who develop severe hemorrhage [].

The following serious adverse reactions are discussed elsewhere in the labeling:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).