Atgam equine

Name: Atgam equine

What is the most important information I should know about this medicine?

You will receive this medicine in a hospital or clinic setting to quickly treat any serious side effects that occur. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

What happens if I overdose?

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

This medicine side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; chest pain, back pain; swelling of your face, lips, tongue, or throat.

Tell your caregivers right away if you have:

  • fast heartbeat, trouble breathing;

  • a light-headed feeling, like you might pass out;

  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin, coughing up blood or vomit that looks like coffee grounds;

  • seizure (convulsions); or

  • low white blood cell counts--fever, swollen glands, skin sores, rash or itching, muscle or joint pain, feeling very weak or tired.

Common side effects may include:

  • fever, chills, night sweats, or other signs of infection;

  • blisters or ulcers in your mouth, red or swollen gums, trouble swallowing;

  • nausea, vomiting, diarrhea;

  • pain where the medicine was injected;

  • red or itching skin;

  • abnormal liver or kidney function tests;

  • dizziness, headache, confusion; or

  • redness, swelling, warmth, irritation, or tenderness in the veins of your arms or legs.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

For the Consumer

Applies to lymphocyte immune globulin, anti-thy (equine): parenteral concentrate for injection

Side effects include:

Renal allotransplantation: Fever, chills, leukopenia, thrombocytopenia, dermatologic reactions (rash, pruritus, urticaria, wheal and flare).

Aplastic anemia: Fever, chills, skin reactions, arthralgia, headache, myalgia, nausea, chest pain, phlebitis, serum sickness.

For Healthcare Professionals

Applies to lymphocyte immune globulin, anti-thy (equine): intravenous solution

General

General side effects have included fever, chills, herpes simplex reactivation, localized infection, systemic infection, possible serum sickness, lymphadenopathy, post-cervical lymphadenopathy, tender lymph nodes and night sweats.[Ref]

Hypersensitivity

Hypersensitivity side effects have included anaphylaxis.[Ref]

Dermatologic

Dermatologic side effects have included rash, pruritus, urticaria, wheal, flare, toxic epidermal necrosis and wound dehiscence.[Ref]

Musculoskeletal

Musculoskeletal side effects have included arthralgia, chest, flank or back pain, leg pains, myalgia, joint stiffness, muscle ache, burning soles, burning palms, and foot sole pain.[Ref]

Gastrointestinal

Gastrointestinal side effects have included GI bleeding or perforation, hiccoughs, epigastric pain, stomach pain, diarrhea, abdominal pain, stomatitis, laryngospasm, nausea and vomiting.[Ref]

Cardiovascular

Cardiovascular side effects have included hypertension, hypotension, tachycardia, congestive heart failure, edema, vasculitis and deep vein thrombosis, thrombophlebitis, clotted A-V fistula, myocarditis, cardiac irregularity, bradycardia, renal artery thrombosis, and iliac vein obstruction.[Ref]

Hematologic

Hematologic side effects have included thrombocytopenia, leukopenia, hepatosplenomegaly, neutropenia or granulocytopenia, anemia and thrombophlebitis.[Ref]

Respiratory

Respiratory side effects have included respiratory distress, dyspnea, apnea, pulmonary edema, bilateral pleural effusion, laryngospasm/edema, cough and sore mouth/throat.[Ref]

Nervous system

Nervous system side effects have included headache, dizziness, paresthesia, weakness or faintness, agitation/lethargy, listlessness, lightheadedness, seizures, malaise, confusion or disorientation, abnormal involuntary movement or tremor, possible encephalitis or post viral encephalopathy and rigidity.[Ref]

Local

Local side effects have included pain at the infusion site.[Ref]

Renal

Renal side effects have included proteinuria.[Ref]

Ocular

Ocular side effects have included periorbital edema.[Ref]

Metabolic

Metabolic side effects have included hyperglycemia.[Ref]

Hepatic

Hepatic side effects have included hepatosplenomegaly.[Ref]

Some side effects of Atgam may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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