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ANAVIP crotalidae immune F(ab)2(equine) 12 mg/mL Injection, Powder, Lyophilized, For Solution — NDC 66621-0790-02 package photo

ANAVIP crotalidae immune F(ab)2(equine) 12 mg/mL Injection, Powder, Lyophilized, For Solution

by Rare Disease Therapeutics, Inc · 1 VIAL in 1 CARTON (66621-0790-2) / 10 mL in 1 VIAL (66621-0790-1)
NDC 66621-0790-02
🏷️ FDA NDC (as labeled) 66621-0790-2 billing pads the package segment with a zero
Brand On market Non-controlled
🗂️ Data synced Sep 25, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 66621-0790-2
Product NDC 66621-0790
11-digit billing NDC 66621079002
NCPDP billing unit EA — each (per item)
Application # BLA125488
SPL Set ID a16596a5-e87e-40c2-8e34-cea5839849c3
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-05-06
Route INTRAVENOUS
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Substance PIT VIPER (CROTALINAE) IMMUNE GLOBULIN ANTIVENIN (EQUINE)
GPI-14 19200022002120
GPI class Anavip
GCN Seq No 020526
GCN 48379
HICL code 004224
Ingredient (HICL) Antivenin,Crotalidae (Equine)
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W7
Therapeutic class — intermediate (HIC2) Biologicals
HIC3 code W7S
Therapeutic class — specific (HIC3) Antivenins
AHFS code 80:04.00.00
AHFS class Antitoxins And Immune Globulins
FDB label name ANAVIP VIAL
FDB brand name Anavip
Legend status F — Federal legend — prescription drug or device
Biologic (Purple Book) 351(a)
Why two NDCs? The FDA registers this code as 66621-0790-2 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 66621-0790-02. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerRare Disease Therapeutics, Inc
FDA applicationBLA125488 (BLA)
Labeler code66621
First marketedMay 2015
Product typePlasma Derivative
Portfolio2 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name ANAVIP VIAL Ingredient Antivenin,Crotalidae (Equine)

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J0841 No ASP payment limit on file for J0841 this quarter.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🧾 Billing & reimbursement

FDA NDC (as labeled)66621-0790-2
11-digit billing NDC66621-0790-02
Format5-4-1 as registered → padded to 5-4-2 for billing (zero added to the package segment)
HCPCS J-codeJ0841
DescriptorINJECTION, CROTALIDAE IMMUNE F(AB')2 (EQUINE), 120 MG
Billing units / pkg2 units
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Anavip 12 mg/mLthis 66621-0790-02 Rare 1 vial — — FDA listed —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & biosimilar status

🏛️
2015
First FDA approval
May 2015
📍
2026
Currently FDA-listed
11 years listed
🛡️
2027
Latest patent/protection listed
not a guaranteed launch date
🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through May 2027. This may affect when biosimilars become widely available, but it is not a guaranteed launch date.
📅 FDA approved May 6, 2015 ⏳ ~0.6 yr to latest listed protection

Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.

Patents & exclusivity — FDA Purple Book
Exclusivity RefProduct
2015 2017 2019 2021 2023 2025 2027
Today
LOE
Biologic patent Exclusivity
🏛️Reference-product exclusivity
A flat 12 years of FDA market protection from first licensure. No biosimilar can be licensed before it ends — regardless of patents.
🧪Listed biologic patents
Patents the reference maker lists covering the molecule, formulation, or manufacturing. A biosimilar generally can’t launch until these resolve.
🔁Interchangeability
An interchangeable biosimilar may be substituted at the pharmacy (state laws vary). The first one can earn its own exclusivity period.
🛈 What do these terms mean?
Biologic patent
A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
Reference-product exclusivity
A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
Interchangeable exclusivity
The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
Earliest biosimilar (LOE)
The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.

Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.

FDA exclusivity
CodeWhat it grantsExpires
RefProductReference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this dateMay 6, 2027
Common questions
Is there a biosimilar for ANAVIP VIAL?
No FDA-licensed biosimilar is currently listed for this biologic in the FDA Purple Book.
Why do different websites show different biosimilar dates?
Biosimilar availability isn’t based on one single date. Some sources use the reference-product exclusivity, some use the last listed patent, and patent litigation, settlements, and licenses can all change the real-world launch date. This page shows the underlying Purple Book dates so you can see why estimates differ.
Can a biosimilar launch before the last patent expires?
Sometimes. A biosimilar maker may settle with the reference manufacturer or receive a license to launch earlier. In other cases, the last listed protection delays competition.
What does “current Purple Book estimate” mean?
It means we’re using the latest patent and exclusivity dates currently listed in the FDA Purple Book. It is not a guaranteed launch date.
What does “FDA listed” mean?
It means the product appears in the FDA’s official directory. That’s a good sign a product exists for the U.S. market, but on its own it does not confirm a pharmacy can get it today. Where we have recent retail pricing data, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Purple Book for a patent or exclusivity on the reference biologic. It can affect when a biosimilar becomes widely available — but it is not a guaranteed launch date. Settlements and licenses can move the real date earlier or later.
Built from the FDA Purple Book Patent List (patents the reference-product sponsor has publicly listed under the BPCIA) plus reference-product exclusivity. Biosimilars cannot launch until these clear; patent litigation and settlements can shift the real date. Biologics have no small-molecule generics — competition comes from FDA-licensed biosimilars, not the Orange Book.
Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
66621-0790-02 You're viewing this 1 VIAL in 1 CARTON (66621-0790-2) / 10 mL in 1 VIAL (66621-0790-1) 2015-05-06 Active

🧭 About this NDC listing & data coverage

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 66621-0790-2, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 66621-0790-02, written without dashes as 66621079002. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 66621-0790-02, the first segment (66621) is the labeler code FDA assigned to Rare Disease Therapeutics, Inc; the middle segment (0790) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Rare Disease Therapeutics, Inc. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Rare Disease Therapeutics, Inc is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J0841 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full FDA label FDA SPL

The complete FDA label for this product, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 54 words ▾

1 INDICATIONS AND USAGE Anavip [Crotalidae Immune F(ab') 2 (Equine)] is an equine-derived antivenin indicated for the management of adult and pediatric patients with North American rattlesnake envenomation.( 1 ) Anavip [Crotalidae Immune F(ab') 2 (Equine)] is an equine-derived antivenin indicated for the management of adults and pediatric patients with North American rattlesnake envenomation.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Intravenous use only. Dose No. of Vials Infusion Rate Initial Dose 10 vials Infuse intravenously over 60 minutes.( 2 ) Additional dose(s) to achieve initial control 10 vial (as needed) Infuse intravenously over 60 minutes.( 2 ) Observation and late dosing 4 vials Infuse intravenously over 60 minutes.( 2 ) Initiate administration as soon as possible after rattlesnake bite in patients who develop signs of envenomation (e.g., local injury, coagulation abnormality, or systemic signs of envenomation).

Monitor patients in a health care setting at least 18 hours following initial control of signs and symptoms. Re-emerging symptoms including coagulapathies may be suppressed with additional 4 vial doses of Anavip as needed.( 2 ) Reconstitute each vial with 10 milliliters (mL) of sterile normal saline. ( 2 ) Combine and further dilute to a total of 250 mL with sterile normal saline.( 2 ) For Intravenous use only.

Administer Anavip as soon as possible after rattlesnake bite in patients who develop any signs of envenomation (e.g., local injury, coagulation abnormality, or systemic signs of envenomation). The amount of antivenin required to treat a snake bitten patient is highly variable owing in part to the venom burden, the potency of the venom and the time to health care presentation. Use supportive measures to treat certain manifestations of rattlesnake envenomation, such as pain, swelling, hypotension, and wound infection.

Contact the local poison control centers for additional individual treatment advice. Prior to initiating treatment perform laboratory analyses, including complete blood count, platelet count, PT, PTT, serum fibrinogen level and routine serum chemistries. Repeat testing at regular intervals to gauge response to therapy and anticipate additional dosing.

Initial Dose: 10 vials The initial dose of Anavip is 10 vials. Reconstitute the contents of each vial with 10 milliliters (mL) of sterile normal saline. Reconstitution time should be less than one minute when using continuous gentle swirling.

Inspect the solution visually for particulate matter and discoloration prior to administration. The solution is expected to be clear to yellow/green and opalescent. Do not use if otherwise discolored or turbid.

Combine the contents of the reconstituted vials promptly and further dilute to a total volume of 250 mL with sterile normal saline. Fluid volumes may need to be adjusted for very small children or infants. Poison Control Centers are a helpful resource for individual treatment advice.

Infuse intravenously over 60 minutes. For the first 10 minutes infuse at a 25-50 mL/hour rate, carefully monitoring for any allergic reactions, including an anaphylactic reactions. Discontinue the infusion if any allergic reaction occurs and institute appropriate emergency treatment.

Reassess the risk to benefit before continuing the infusion. If no reactions occur, the infusion rate may be increased to the full 250 mL/hour rate until completion. If there is any allergic reaction at any time, stop the infusion, treat accordingly, and reassess the need to continue Anavip.

Following the completion of infusion, monitor the patient for at least 60 minutes for any allergic reaction and to determine that local signs of envenomation are not progressing (leading edge of local injury not progressing), systemic symptoms are resolved and coagulation parameters have normalized or are trending toward normal. Discard partially or unused reconstituted and diluted product. Additional Dosing to Achieve Initial Control Administer additional 10 vial doses if needed to arrest the progressive symptoms and repeat every hour.

There is no known maximum dose. Repeat above steps for initial dose as many times as needed until local signs of envenomation are not progressing, systemic symptoms are resolved and coagulation parameters have normalized or are trending toward normal. Prepare as described above for initial dose.

Once initial control h…

💊 Dosage Forms and Strengths 104 words ▾

Each vial contains a sterile, lyophilized preparation containing not more than 120 milligrams total protein and not less than the indicated number of mouse LD 50 neutralizing units ( 3 ): Snake Species Used for Standardization Minimum Mouse LD 50 Units per Vial Bothrops asper 780 Crotalus durissus 790

3 DOSAGE FORMS AND STRENGTHS Anavip is supplied as a sterile, lyophilized powder. Each vial contains not more than 120 milligrams (mg) total protein and not less than the indicated number of mouse LD 50 neutralizing units: Snake Species Used for Standardization Minimum Mouse LD 50 Units per Vial Bothrops asper 780 Crotalus durissus 790

⛔ Contraindications 6 words ▾

None.( 4 )

4 CONTRAINDICATIONS None.

⚠️ Warnings and Cautions 113 words ▾

Anavip may cause allergic reactions Patients with known allergies to horse protein are particularly at risk for an anaphylactic reaction. If signs or symptoms of anaphylaxis or hypersensitivity reactions (including urticaria, rash, tightness of the chest, wheezing, hypertension) occur, discontinue immediately and institute appropriate treatment. Monitor patients with follow-up visits for signs and symptoms of delayed allergic reactions or serum sickness (rash, fever, myalgia, arthralgia, pruritus, urticarial rash) and treat appropriately if necessary.( 5.1 ) Anavip is made from equine plasma and may contain infectious agents, e.g. viruses.( 5.2 ) Localized reactions and generalized myalgias have been reported with the use of cresol as an injectable excipient.( 5.3 )

5 WARNINGS AND PRECAUTIONS

🤒 Adverse Reactions 82 words ▾

The most common adverse reactions (>2%)in the clinical studies were: pruritus, nausea, rash, arthralgia, peripheral edema, myalgias, headache, pain in extremity, vomiting and erythema.( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Rare Disease Therapeutics, Inc., at 1 877-851-1902, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6 ADVERSE REACTIONS The most common adverse reactions observed in more than 2 percent of patients in the clinical trials for Anavip were: pruritus, nausea, rash, arthralgia, peripheral edema, erythema, headache, myalgia, pain in extremity, and vomiting.

👥 Use in Specific Populations 18 words ▾

Pregnancy: No human or animal data. Use only if clearly needed.( 8.1 )

8 USE IN SPECIFIC POPULATIONS

🤰 Pregnancy 48 words ▾

8.1Pregnancy Pregnancy Category C: Animal reproduction studies have not been conducted with Anavip. It is also not known whether Anavip can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Anavip should be given to a pregnant woman only if clearly needed.

🧒 Pediatric Use 99 words ▾

8.4Pediatric Use Twenty-four percent (21/86) of patients studied in clinical trials were 16 years of age or younger (6 patients were 2 years of age to 5 years of age, 15 patients ranged from at least 5 years of age to 16 years of age). None of the pediatric patients in the phase 3 study experienced a recurrent coagulopathic effect. All adverse reactions in the pediatric patients were non-serious.

The most frequent adverse reactions among pediatric patients were nausea and vomiting, itching and fever. Thus, the safety and efficacy in the pediatric population was not different from adults.

🧓 Geriatric Use 33 words ▾

8.5Geriatric Use Over 9 percent (8/86) of patients studied in clinical trials were over 65 years of age. The efficacy of Anavip in the geriatric population appears comparable to the overall population.

🧬 Clinical Pharmacology 198 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Anavip contains venom-specific F(ab') 2 fragments of immunoglobulin G (IgG) that bind and neutralize venom toxins, facilitating redistribution away from target tissues and elimination from the body. 1,2

12.3Pharmacokinetics Fourteen healthy volunteers each received one vial of intravenous (IV) doses (one vial = 81.86 mg) of an antivenin comparable to Anavip both in composition and manufacturing. On the first day of antivenin administration, blood samples were collected from all subjects at 16 specific time points: 0 (prior to drug infusion), 5, 10, 20, 30, 45, 60, 120, and 480 minutes after drug infusion. Additional samples were drawn just prior to discharge (Day 1), and on days 3, 5, 7, 9, 11, and 21.

A two-compartment model best described the concentration-time data. The pharmacokinetic parameters of the antivenin are summarized in Table 2. Table 2.

Pharmacokinetic Parameters of Anavip Antivenin Following a Single IV Dose to Healthy Volunteers (n=13) Units Mean SD Area under plasma concentration vs time curve AUC 0-∞ (µg•h/mL) 4144 670 Steady-state volume of distribution Vss (L) 3.3

0.9Mean residence time MRT (h) 157 40 Elimination half-life Beta-HL (h) 133 53 Total Clearance CL (mL/h) 22 7

🧬 Mechanism of Action 32 words ▾

12.1Mechanism of Action Anavip contains venom-specific F(ab') 2 fragments of immunoglobulin G (IgG) that bind and neutralize venom toxins, facilitating redistribution away from target tissues and elimination from the body. 1,2

📦 How Supplied / Storage and Handling 103 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Anavip is supplied as a sterile lyophilized preparation in a single-use vial. When reconstituted with 10 mL of 0.9% NaCl solution, each vial contains not more than 12 mg per mL of protein, and will neutralize not less 780 times the LD 50 of Bothrops asper venom and 790 times the LD 50 of Crotalus durissus venom in a mouse neutralization assay. Each box contains 1 vial of Anavip.

NDC 66621-0790-1 Store at room temperature (up to 25 ºC (77 ºF)). Brief temperature excursions are permitted up to 40 ºC (104ºF). DO NOT FREEZE.

Discard partially used vials.

📋 Description 193 words ▾

11 DESCRIPTION Anavip [Crotalidae Immune F(ab') 2 (Equine)] is a sterile, lyophilized, polyvalent preparation of equine immunoglobulin F(ab') 2 fragments, manufactured from plasma of horses immunized with venom of Bothrops asper and Crotalus durissus . The product is obtained by pepsin digestion of horse plasma to remove the F c portion of immunoglobulin, followed by fractionation and purification steps. The F(ab') 2 content is not less than 85%, F(ab') content is not more than 7%, and the product contains less than 5% intact immunoglobulin.

Each vial of Anavip contains 25.2-56.8 mg of sodium chloride, 18.2 - 85.8 mg of sucrose, and 16.2-51.8 mg of glycine as stabilizers. Trace amounts of pepsin (≤160 ng/vial), cresol (≤0.99 mg/vial), borates (≤1 mg/vial) and sulfates (≤1.7 mg/vial) may be present from the manufacturing process. Each vial contains no more than 120 mg of protein and will be neutralize not less than 780 times the LD 50 of Bothrops asper venom and 790 times the LD 50 of Crotalus durissus venom in a mouse neutralization assay.

The manufacturing procedures that contribute to the reduction of risk of viral transmission include pepsin digestion, ammonium sulfate precipitation/heat treatment and nanofiltration.

💬 Information for Patients 133 words ▾

17 PATIENT COUNSELING INFORMATION Advise patients to contact their physician immediately if they experience unusual bruising or bleeding (e.g., nosebleeds, excessive bleeding after brushing teeth, the appearance of blood in stools or urine, excessive menstrual bleeding, petechiae, excessive bruising or persistent oozing from superficial injuries) after hospital discharge. 5 Advise patients to contact their physician immediately if they experience any signs and symptoms of delayed allergic reactions or serum sickness (e.g., rash, fever, myalgias, arthralgia, pruritus, urticaria) after hospital discharge.

4 Manufactured by: Instituto Bioclon S.A. de C.V. Mexico D.F., Mexico www.bioclon.com.mx Manufactured for: Rare Disease Therapeutics, Inc. 2550 Meridian Blvd., Suite 150 Franklin, TN 37067 www.raretx.com Distributed by: AnovoRx Distribution, LLC 1710 North Shelby Oaks Drive Suite 6 Memphis, TN 38134 U.S.

License No. 1900 RDT Part No. Anavip PI001 PACKAGE LABEL

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 66621-0150-02 · Rare 66639-0001-00 · Calyx →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.