AHZANTIVE 40 mg/mL
aflibercept-mrbb · INJECTION, SOLUTION · Valorum Biologics, LLC
Aflibercept-Mrbb (Ahzantive) is an injectable medication administered directly into the eye to treat certain eye conditions involving abnormal blood vessel growth. Your doctor will determine if this treatment is appropriate for your specific eye condition and will handle all administration.
Key Facts
- Brand Name
- AHZANTIVE
- Generic Name
- aflibercept-mrbb
- NDC Code (Product)
85006-2908- Manufacturer
- Valorum Biologics, LLC
- Strength
- 40 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVITREAL
- Marketing Status
- Application #
- BLA761378
- Marketing Start
- 06/01/2024
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
These highlights do not include all the information needed to use AHZANTIVE safely and effectively. See full prescribing information for AHZANTIVE. Initial U.S. Approval: 2024 1 INDICATIONS AND USAGE AHZANTIVE is indicated for the treatment of: 1.1 Neovascular (Wet) Age-Related Macular Degeneration (AMD) 1.2 Macular Edema Following Retinal Vein Occlusion (RVO) 1.3 Diabetic Macular Edema (DME) 1.4 Diabetic Retinopathy (DR) AHZANTIVE is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (AMD) (1.1) Macular Edema Following Retinal Vein Occlusion (RVO) (1.2) Diabetic Macular Edema (DME) (1.3) Diabetic Retinopathy (DR) (1.4)
Dosage & Administration
2. DOSAGE AND ADMINISTRATION 2.1 Important Injection Instructions For ophthalmic intravitreal injection. AHZANTIVE must only be administered by a qualified physician. Pre-filled Syringe: A 30-gauge × ½-inch sterile injection needle is needed but not provided. Vial: A 5-micron sterile filter needle (18-gauge × 1½-inch), a 1-mL sterile Luer lock syringe and a 30‑gauge × ½-inch sterile injection needle are needed, but not provided. AHZANTIVE is available packaged as follows: Pre-filled Syringe. The AHZANTIVE pre-filled syringe cap and plunger are not made with natural rubber latex. Vial Only. The AHZANTIVE vial stopper is not made with natural rubber latex. [see How Supplied/Storage and Handling (16)]. 2.2 Neovascular (Wet) Age-Related Macular Degeneration (AMD) The recommended dose for AHZANTIVE is 2 mg (0.05 mL of 40 mg/mL solution) administered by intravitreal injection every 4 weeks (approximately every 28 days, monthly) for the first 12 weeks (3 months), followed by 2 mg (0.05 mL of 40 mg/mL solution) via intravitreal injection once every 8 weeks (2 months). Although AHZANTIVE may be dosed as frequently as 2 mg every 4 weeks (approximately every 25 days, monthly), additional effi…
Contraindications
4. CONTRAINDICATIONS 4.1 Ocular or Periocular Infections AHZANTIVE is contraindicated in patients with ocular or periocular infections. 4.2 Active Intraocular Inflammation AHZANTIVE is contraindicated in patients with active intraocular inflammation. 4.3 Hypersensitivity AHZANTIVE is contraindicated in patients with known hypersensitivity to aflibercept or any of the excipients in AHZANTIVE. Hypersensitivity reactions may manifest as rash, pruritus, urticaria, severe anaphylactic/anaphylactoid reactions, or severe intraocular inflammation. Ocular or periocular infections (4.1) Active intraocular inflammation (4.2) Hypersensitivity (4.3)
Adverse Reactions
6 ADVERSE REACTIONS The following potentially serious adverse reactions are described elsewhere in the labeling: Hypersensitivity [see Contraindications (4.3)] Endophthalmitis, Retinal Detachments, and Retinal Vasculitis with or without Occlusion [see Warnings and Precautions (5.1)] Increase in intraocular pressure [see Warnings and Precautions (5.2)] Thromboembolic events [see Warnings and Precautions (5.3)] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in other clinical trials of the same or another drug and may not reflect the rates observed in practice. A total of 2980 adult patients treated with aflibercept constituted the safety population in eight phase 3 studies. Among those, 2379 patients were treated with the recommended dose of 2 mg. Serious adverse reactions related to the injection procedure have occurred in <0.1% of intravitreal injections with aflibercept including endophthalmitis and retinal detachment. The most common adverse reactions (≥5%) reported in patients receiving aflibercept were conjunctival hemorrha…
Frequently Asked Questions
What is AHZANTIVE used for?
Aflibercept-Mrbb (Ahzantive) is an injectable medication administered directly into the eye to treat certain eye conditions involving abnormal blood vessel growth. Your doctor will determine if this treatment is appropriate for your specific eye condition and will handle all administration.
Is AHZANTIVE a controlled substance?
AHZANTIVE is not classified as a controlled substance by the DEA.
What is the generic name for AHZANTIVE?
The generic name for AHZANTIVE is aflibercept-mrbb. There are no other listed brand versions of aflibercept-mrbb.
What is the NDC code for AHZANTIVE 40 mg/mL?
The NDC (National Drug Code) for AHZANTIVE 40 mg/mL is 85006-2908, listed by Valorum Biologics, LLC.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)