Anascorp Injection

Name: Anascorp Injection

Anascorp Injection Dosage and Administration

For Intravenous use only.


Initiate treatment with Anascorp as soon as possible after scorpion sting in patients who develop clinically important signs of scorpion envenomation, including but not limited to loss of muscle control, roving or abnormal eye movements, slurred speech, respiratory distress, excessive salivation, frothing at the mouth and vomiting.(2)


Initial Dose: 3 vials

  • The initial dose of Anascorp is 3 vials.
  • Reconstitute the contents of each vial with 5 milliliters of sterile normal saline and mix by continuous gentle swirling.
  • Combine the contents of the reconstituted vials promptly and further dilute to a total volume of 50 milliliters with sterile normal saline.
  • Inspect the solution visually for particulate matter and discoloration prior to administration. Do not use if turbid.
  • Infuse intravenously over 10 minutes.
  • Monitor patient closely during and up to 60 minutes following the completion of infusion to determine if clinically important signs of envenomation have resolved.
  • Discard partially used vials.

Initial Dose: 3 vials

  • Additional doses may be used if needed.
  • Infuse one vial at a time at intervals of 30 to 60 minutes.
  • Reconstitute the contents with 5 milliliters of sterile normal saline and mix by continuous gentle swirling.
  • Further dilute to a total volume of 50 milliliters with sterile normal saline. Inspect the solution visually for particulate matter or discoloration prior to administration.
  • Infuse intravenously over 10 minutes.
  • Monitor patient closely during and up to 60 minutes following the completion of infusion to determine if clinically important signs of envenomation have resolved.
  • Discard partially used vials.

Dosage Forms and Strengths

Each vial of Anascorp contains a sterile, lyophilized preparation containing not more than 120 milligrams total protein and not less than 150 LD50 (mouse) neutralizing units.

Contraindications

None.

Warnings and Precautions

Hypersensitivity Reactions

Severe hypersensitivity reactions, including anaphylaxis, may occur with Anascorp. Close patient monitoring for hypersensitivity reactions and readiness with intravenous therapy using epinephrine, corticosteroids, and diphenhydramine hydrochloride is recommended during the infusion of Anascorp. If an anaphylactic reaction occurs during the infusion, terminate administration at once and administer appropriate emergency medical care.
Patients with known allergies to horse protein are particularly at risk for an anaphylactic reaction. Patients who have had previous therapy with Anascorp or another equine antivenom/antitoxin may have become sensitized to equine protein and be at risk for a severe hypersensitivity reaction.

Delayed Allergic Reactions (Serum Sickness)

Monitor patients with follow-up visit(s) for signs and symptoms of delayed allergic reactions or serum sickness (e.g., rash, fever, myalgia, arthralgia), and treat appropriately if necessary. Eight out of 1,534 (0.5%) patients in the clinical trials exhibited symptoms suggestive of serum sickness. (6.1)

Transmissible Infectious Agents

Anascorp is made from equine (horse) plasma, it may therefore carry a risk of transmitting infectious agents, e.g., viruses.

Reaction to Cresol

Trace amounts of cresol from the manufacturing process are contained in Anascorp. Localized reactions and generalized myalgias have been reported with the use of cresol as an injectable excipient.

Adverse Reactions

The most common adverse reactions observed in ≥ 2% of patients in the clinical studies for Anascorp were: vomiting, pyrexia, rash, nausea and pruritus.

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 the clinical trials of another drug and may not reflect the rates observed in clinical practice.

A total of 1534 patients were treated with Anascorp, ranging from less than one month to 90 years old. The patient population was comprised of 802 males and 732 females. Patients were monitored for signs and symptoms of adverse reactions, including acute hypersensitivity reactions and serum sickness. Follow-up telephone interviews were conducted at 24 hours, 7 days, and 14 days after treatment to assess symptoms suggestive of ongoing venom effect, serum sickness, and any other adverse reactions. Table 1 shows the adverse reactions occurring in patients across all clinical trials for Anascorp. Twenty-seven percent (421/1534) of patients receiving Anascorp reported at least one adverse reaction.

Table 1: Adverse Reactions Reported in ≥ 1% of Patients
ADVERSE REACTIONS Anascorp [N=1534]
n(%)
Vomiting 72 (4.7)
Pyrexia 63 (4.1)
Rash 41 (2.7)
Nausea 32 (2.1)
Pruritus 31 (2.0)
Headache 29 (1.9)
Rhinorrhoea 28 (1.8)
Myalgia 25 (1.6)
Fatigue 24 (1.6)
Cough 22 (1.4)
Diarrhea 20 (1.3)
Lethargy 17 (1.1)

No patients died or discontinued study participation for severe adverse reactions.

Eight patients were considered to have serum sickness (Type III hypersensitivity); no patient manifested the full serum sickness syndrome. Three patients were treated with systemic corticosteroids and five others received either no treatment or symptomatic therapy.

34 patients experienced a total of 39 severe adverse reactions such as respiratory distress, aspiration, hypoxia, ataxia, pneumonia, and eye swelling. It is not clear whether these adverse reactions were related to Anascorp envenomation or a combination of both.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of Anascorp. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Chest tightness, palpitations, rash and pruritus.

Patient Counseling Information

Advise patients to contact the physician or emergency department immediately if they experience any signs and symptoms of delayed allergic reactions or serum sickness up to 14 days following hospital discharge. Symptoms include rash, pruritus, joint pain, arthralgia, fever, lymphoadenopathy, and malaise.



Manufactured by:

Instituto Bioclon S.A. de C.V.

Mexico D.F., Mexico

www.bioclon.com.mx



Manufactured for:

Rare Disease Therapeutics

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. 1860



RDT Part No. Anascorp PI002




PACKAGE LABEL

Anascorp Carton label

Anascorp Vial label

ANASCORP 
centruroides (scorpion) immune f(ab)2 (equine) injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:66621-0150
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CENTRUROIDES FAB2 ANTIVENIN (EQUINE) (CENTRUROIDES FAB2 ANTIVENIN (EQUINE)) CENTRUROIDES FAB2 ANTIVENIN (EQUINE) 24 mg  in 1 mL
Packaging
# Item Code Package Description
1 NDC:66621-0150-1 1 VIAL (VIAL) in 1 CARTON
1 10 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125335 08/03/2011
Labeler - Rare Disease Therapeutics, Inc (966133100)
Registrant - Rare Disease Therapeutics, Inc (966133100)
Establishment
Name Address ID/FEI Operations
Instituto Bioclon S.A. de C.V. 811974559 manufacture(66621-0150)
Revised: 12/2013   Rare Disease Therapeutics, Inc
(web3)