Medical Editor: John P. Cunha, DO, FACOEP
Thrombate III (Antithrombin III [Human]) is a form of protein found in the blood used to treat patients with hereditary antithrombin III deficiency in connection with surgical or obstetrical procedures or when they suffer from thromboembolism. Common side effects of Thrombate III include:
- chest tightness or pain
- foul or unusual taste in mouth
- shortness of breath
- film over eye
- bowel fullness
- oozing and
- blood blister formation
Dosage should be determined on an individual basis based on the pre-therapy plasma antithrombin III (AT-III) level, in order to increase plasma AT-III levels to the level found in normal human plasma (100%). Thrombate III may interact with heparin. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before starting treatment with Thrombate III. Consult your doctor before breastfeeding.
Our Thrombate III (Antithrombin III [Human]) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
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.
Clinical Trials Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of one drug cannot be directly compared to rates in other clinical trials of another drug and may not reflect the rates observed in clinical practice.
Two clinical trials were conducted in 33 subjects with congenital AT deficiency. The first was a prospective, open-label, dose-escalation, dose-ranging, and pharmacokinetic study in 11 asymptomatic subjects. Eight subjects received a single dose, escalated sequentially, followed by weekly dose ranging from 25 to 125 unit/kg. Five subjects (including 2 from the first part of the study) received weekly THROMBATE III for periods of up to 23 weeks in doses ranging from 125 to 225 unit/kg. The second trial was a phase III, prospective, open-label study conducted in 24 subjects for additional kinetics (n=3), the prevention of thrombosis (n=13) during high risk conditions (pregnancy, surgery), or the treatment of thrombosis (n=10). Loading doses targeted an AT plasma level of 120% and ranged from 33 to 150 unit/kg. Maintenance doses targeted a plasma AT range of 70% to 120%, which were 23 to 75 unit/kg.
Adverse reactions reported during the 2 clinical trials are listed in Table 2. Nine subjects (27%) experienced 29 adverse reactions which occurred during 17 of 389 infusions. There were no serious adverse reactions reported. The severity of adverse reactions was reported as mild or moderate, except for wound secretion and hematoma, which was severe.
Table 2: Adverse Reactions Occurring during Hereditary
|Adverse Reaction*||Number of Subjects with Adverse Reaction (%)†||Number of Adverse
(% of All Infusions)‡
|Any adverse reaction||9 (27)||29 (7.5)|
|Dizziness||4 (12)||8 (2.1)|
|Chest discomfort||3 (9)||3 (0.8)|
|Nausea||3 (9)||3 (0.8)|
|Dysgeusia||2 (6)||3 (0.8)|
|Pain (cramps)||2 (6)||2 (0.5)|
|Chills||1 (3)||2 (0.5)|
|Wound secretion and hematoma||1 (3)||2 (0.5)|
|Vision blurred||1 (3)||1 (0.3)|
|Chest pain||1 (3)||1 (0.3)|
|Dyspnea||1 (3)||1 (0.3)|
|Intestinal dilatation||1 (3)||1 (0.3)|
|Pyrexia||1 (3)||1 (0.3)|
|Urticaria||1 (3)||1 (0.3)|
|*MedDRA Preferred Term; an adverse reaction is defined as any
adverse event where either a) the event was related, or possibly
related to the drug, b) the occurrence was during infusion or
shortly after treatment, or c) the event recurred after withdrawal
and re-administration (challenge/dechallenge).
†N = 33 subjects
‡N = 389 infusions
During clinical investigation of THROMBATE III, there were no reports of virus transmission. None of 12 subjects monitored for a median of 8 months (range 2–19 months) after receiving THROMBATE III became antibody positive to human immunodeficiency virus (HIV-1). None of 14 subjects monitored for ≥ 3 months demonstrated any evidence of hepatitis.
Read the entire FDA prescribing information for Thrombate (Antithrombin)