Crotalidae Immune F(Ab)2(Equine) (Anavip)

Trade Name : ANAVIP

Rare Disease Therapeutics, Inc

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION, PLASMA DERIVATIVE

Strength 12 mg/mL

PIT VIPER (CROTALINAE) IMMUNE GLOBULIN ANTIVENIN (EQUINE)

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Crotalidae Immune F(Ab)2(Equine) (Anavip) which is also known as ANAVIP and Manufactured by Rare Disease Therapeutics, Inc. It is available in strength of 12 mg/mL per ml. Read more

Crotalidae Immune F(Ab)2(Equine) (Anavip) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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ANAVIP [crotalidae immune F(ab') (equine)] is an equine-derived antivenin indicated for the management of adult and pediatric patients with North American rattlesnake envenomation. ntttt
nttttttttANAVIP [crotalidae immune F(ab') (equine)] is an equine-derived antivenin indicated for the management of adult and pediatric patients with North American rattlesnake envenomation. ()nttttttt

Intravenous use only

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 an additional 4 vial doses of ANAVIP as needed. ()
Reconstitute each vial with 10 milliliters (mL) of sterile normal saline (0.9% NaCl). ()
Combine and further dilute to a total of 250 mL with sterile normal saline (0.9% NaCl). ()

ANAVIP [crotalidae immune F(ab') (equine)] is a sterile, lyophilized, polyvalent preparation of equine immunoglobulin F(ab') fragments,nttttmanufactured from plasma of horses immunized with venom of and . The product is obtained by pepsin digestion of horse plasma to remove the F portion of immunoglobulin, followed by fractionation and purification steps.nttttThe F(ab') content is not less than 85%, F(ab') content is not more than 7%, and the product contains less than 5% intact immunoglobulin. nttttEach 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 (u2264160 ng/vial), cresol (u22640.058 mg/vial), borates (u22641 mg/vial) and sulfates (u22641.7 mg/vial) may be present from the manufacturing process. nttttEach vial contains no more than 120 mg of protein and will be neutralize not less than 780 times the LD of venom and 790 times the LD of venom in a mouse neutralization assay.n nttttThe manufacturing procedures that contribute to the reduction of risk of viral transmission include pepsin digestion, ammonium sulfate precipitation/heat treatment nttttand nanofiltration.

No data

In a published non-GLP study, ANAVIP and another licensed pit viper antivenin were tested and cross-reactivity to the venoms of multiple different pit vipers including rattlesnakes was demonstrated in rabbits and mice. nttt Animal studies to determine a NOAEL were unsuccessful due to technical limitations that prevented determination of a systematically toxic dose.n

ntttttntttttStudy 1 was a randomized, prospective, open-label, controlled, comparative, multicenter study was conducted in 12 patients aged 18 to 70 years of age with signs of pit viper envenomation. ntttttThe subjects received either a licensed pit viper antivenin as an active control, or ANAVIP. The subjects were dosed until initial control was achieved, followed by maintenance doses. ntttttAll patients in both treatment groups achieved initial control of local injury and coagulopathy following early antivenin treatment. n ntttttIn the active control group, at the end of maintenance dosing, 5 of 6 subjects had platelet counts above 150,000/mm, and all 6 had fibrinogen levels above 150 mg/dL. ntttttDuring the follow-up phase two patients exhibited platelets below 150,000/mm and fibrinogen below 150 mg/dL, leading to inpatient management with administration of additional doses nttttt(one subject received an additional 6 doses (12 vials) and one subject received an additional 4 doses (8 vials).ttttt ntttttn ntttttIn the ANAVIP arm, at the end of maintenance dosing, 5 of 6 subjects had platelet counts above 150,000/mm. One subjectu2019s platelets were 114,000/mm and were trending upward and all 6 had fibrinogen levels above 150 mg/dL. ntttttDuring the follow-up phase, 5 of 6 subjects had platelet counts above 150,000/mm, with no downward trend; 1 subjectu2019s platelet counts was 127,000/mm on follow-up Day 1, reached 160,000/mm on Day 4 and continued trending upward. ntttttAll 6 subjects in the ANAVIP group had fibrinogen levels above 150 mg/dL during the follow-up phase. None in the ANAVIP group required rehospitalization or retreatment with ANAVIP.ntttttn ntttttntttttStudy 2 was a randomized, prospective, blinded, controlled, comparative, multicenter study, comparing two ANAVIP regimens with a licensed pit viper antivenin (comparator) conducted in patients with pit viper envenomation at 16 sites in the United States. ntttttThe study had an in-hospital Acute Treatment Phase that included screening and baseline assessments, initial and maintenance dosing, and an outpatient Follow-up Phase that included 4 follow-up visits on Days 5, 8, 15 and 22.ntttttn n ntttttPatients were randomized in a 1:1:1 ratio to one of three groups: ANAVIP with ANAVIP maintenance therapy (Group 1), ANAVIP with placebo maintenance therapy (Group 2), or Comparator product with Comparator product maintenance therapy (Group 3). ntttttn nntttttInitial dosing consisted of sequential intravenous (IV) doses infused to achieve initial control. If initial control of envenomation was not achieved, treatment was repeated until initial control was attained. Maintenance dosing (4 vials of ANAVIP or placebo [normal saline (0.9% NaCl)], or 2 vials of comparator product) was initiated 6 hours after the start of the last dose required to achieve initial control, and continued every 6 hours for 3 doses.ntttttn ntttttntttttThe Follow-up Phase began immediately after the third maintenance dose. Patients returned to the clinical site on Days 5, 8, and 15 for scheduled follow-up visits. Patients with ongoing signs of envenomation received 4 vials of ANAVIP or 2 vials of Comparator product. Dosing was provided as needed until the patient was stabilized. One hundred twenty-one (121) patients received blinded study drug and were analyzed for safety and efficacy.ntttttn nntttttThe efficacy endpoint was the proportion of patients experiencing coagulopathic effect as measured on Study Day 5 or 8. Patients were assessed as experiencing a coagulopathic effect if they had any one of the following: absolute platelet levels < 150,000/mm as measured on either ntttttStudy Day 5 (u00b11 day) or 8 (u00b11 day); absolute fibrinogen levels <150 mg/dL as measured on either Study Day 5 (u00b11 day) or 8 (u00b11 day); or clinical coagulopathy between end of maintenance dosing and Study Day 5 requiring additional antivenin. ntttttThe comparison of coagulopathic effect proportions between treatment groups was tested using an exact logistic regression model with terms for treatment and region. ntttttComparisons of the proportion of coagulopathic effect for two levels of ANAVIP versus Comparator product were performed in the following order: ANAVIP with ANAVIP maintenance dose versus Comparator product; then ANAVIP with Placebo maintenance dose versus Comparator product. The number and percentage of patients who experienced coagulopathic effect is summarized by treatment group in Table 3.ntttttThe efficacy analysis did not meet the pre-specified statistically defined superiority criterion. However, the percentages of subjects showing prespecified criteria for coagulopathic effect on either Day 5 and/or Day 8 were 10.3% and 5.3% in the Groups 1 and 2 when compared to 29.7% in Group 3 indicating efficacy of ANAVIP in management of coagulopathic effect in patients with North American rattlesnake envenomation.nnttttt
ntttttu00a0u00a0u00a0Cl= confidence intervaln ntttttFDA conducted a post hoc analysis to assess the outcomes of the patients who presented with or without baseline coagulopathic effect in the three treatment groups. ntttttUsing the pre-specified criteria for coagulopathic effect, it was found that ANAVIP/ANAVIP (Group 1) had the highest percentage of baseline coagulopathic subjects among the three groups [41.5% compared with 17.5% and 32.5% for the ANAVIP/Placebo (Group 2) and Comparator product (Group 3), respectively]. ntttttThirty-three percent (33%) of all baseline coagulopathic subjects also experienced coagulopathic effect on either Day 5 or 8, compared to only 6% for baseline non-coagulopathic subjects. ntttttOnly 18% of the subjects with baseline coagulopathic effect in Group 1 continued to remain coagulopathic at Days 5 or 8 compared to 58% in Group 3 (Table 4).nttttt
tAn exact logistic regression analysis adjusting for baseline coagulopathic effect and region was conducted and showed that treatment effect for both Groups 1 and 2 is statistically significant (Table 5). This analysis provides supportive evidence of the efficacy of ANAVIP.
ntttttu00a0u00a0u00a0Cl= confidence intervaln ntttttAnalysis by snakebite type was performed but was limited due to the number of unknown snakebite types (N=43). However, 57 subjects who were envenomated by rattlesnakes showed more severe coagulopathic effects and resolution of these effects after treatment with ANAVIP as compared to 21 subjects who were envenomated by copperhead snakes. ntttttEfficacy outcomes could not be evaluated in the copperhead snake bite subgroup due to these limited coagulopathic effects.n

1. Seifert SA and Boyer LV: Recurrence phenomena after immunoglobulin therapy for snake envenomation: Part 1. Pharmacokinetics and pharmacodynamics of immunoglobulin antivenoms and related antibodies. 37(2):189-195; 2001.
2. Boyer LV, Seifert SA and Cain JS: Recurrence phenomena after immunoglobulin therapy for snake envenomation: Part 2. Guidelines for clinical management with crotaline Fab antivenom. 37(2):196-201; 2001.
3. Sanchez EE, Galan JA, Perez JC, et al. The efficacy of two antivenoms against the venom of North American snakes, 41: 357-365; 2003.
4. Gold BS, Dart RC and Barish RA: Bites of venomous snakes. 347(5):347-56; 2002.
5. Boyer LV, Seifert SA, Clark RF, et al: Recurrent and persistent coagulopathy following pit viper envenomation. 159:706-710; 1999.
6. Boyer LV, Chase PB, Degan JA, et al: Subacute coagulopathy in a randomized, comparative trial of Fab and F(abu2019) antivenoms. 74: 101-108; 2013.

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 of venom and 790 times the LD of nttttvenom in a mouse neutralization assay.
Each carton NDC 66621-0790-2 contains 1 vial of ANAVIP NDC 66621-0790-1.

Manufactured by:
Laboratorios Silanes S.A. de C.V.
Toluca, Estado de Mexico, Mexico
Manufactured for:
Rare Disease Therapeutics, Inc.
2550 Meridian Blvd., Suite 150
Franklin, TN 37067
www.raretx.com
U.S. License No. 1860
RDT Part No. ANV-PI-006
Silanes Part number:360893-5
Arrayn- PACKAGE LABEL

Anavip Carton label
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Crotalidae Immune F(Ab)2(Equine) (Anavip)

Trade Name : ANAVIP

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION, PLASMA DERIVATIVE

Delivery Process

Product information is meant for

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

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Crotalidae Immune F(Ab)2(Equine) (Anavip)

Trade Name : ANAVIP

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION, PLASMA DERIVATIVE

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

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Fluoxetine Hydrochloride (Fluoxetine)

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