ANAVIP Safety Profile5

Pooled adverse reaction data by body system (N=86)5

65 (76%)
Patients reporting at least one adverse event
47 (55%)
Skin and subcutaneous tissue disorders
37 (43%)
Pruritus
10 (12%)
Rash
4 (5%)
Blister
3 (4%)
Erythema
28 (33%)
Gastrointestinal disorders
20 (23%)
Nausea
5 (6%)
Vomiting
19 (22%)
Musculoskeletal and connective tissue disorders
9 (11%)
Arthralgia
6 (7%)
Myalgia
5 (6%)
Pain in extremity
21 (24%)
General disorders and administration site conditions
7 (8%)
Edema, peripheral
3 (4%)
Chills
4 (5%)
Pyrexia
12 (14%)
Nervous system disorders
5 (6%)
Headache
4 (5%)
Psychiatric Disorders
2 (2%)
Anxiety
2 (2%)
Insomnia
4 (5%)
Metabolism and nutrition disorders
2 (2%)
Dehydration
5 (6%)
Respiratory, throacic, and mediastinal disorders
1 (1%)
Dyspnea
2 (2%)
Blood lymphatic system disorders
1 (1%)
Thrombocytopenia

No drug-related serious adverse reactions seen in clinical trials1

  • While 9 patients experienced serious adverse reactions after receiving ANAVIP, all were considered unrelated to ANAVIP1

Comparable safety profile with low incidence of immune reactions1

  • In the Phase 3 trial, the plasma source and molecular structure were not associated with an increase in immune reactions
    or miscellaneous adverse reactions1

    • 1 patient in each study group experienced acute serum reaction. All 3 patients tolerated subsequent doses after resolution1
    • 1 patient in each study group experienced symptoms suggestive of serum sickness. No immune reaction was severe1
Important Safety Information
INDICATION

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.

CONTRAINDICATIONS

None.

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.

WARNINGS AND PRECAUTIONS

Hypersensitivity
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, hypotension) 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.

Transmissible Infectious Agents
ANAVIP is made from equine (horse) plasma and may therefore carry a risk of transmitting infectious agents, e.g., viruses.

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

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