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Drug overview for ADZYNMA (adamts13, recombinant-krhn):
Generic name: ADAMTS13, recombinant-krhn
Drug class: Agents to treat Thrombotic Thrombocytopenic Purpura (TTP)
Therapeutic class: Hematological Agents
ADAMTS13, recombinant-krhn is a human recombinant form of the endogenous ''A disintegrin and metalloproteinase with thrombospondin motifs 13'' (rADAMTS13) enzyme.
No enhanced Uses information available for this drug.
Generic name: ADAMTS13, recombinant-krhn
Drug class: Agents to treat Thrombotic Thrombocytopenic Purpura (TTP)
Therapeutic class: Hematological Agents
ADAMTS13, recombinant-krhn is a human recombinant form of the endogenous ''A disintegrin and metalloproteinase with thrombospondin motifs 13'' (rADAMTS13) enzyme.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for ADZYNMA (adamts13, recombinant-krhn) have been approved by the FDA:
Indications:
Congenital thrombotic thrombocytopenic purpura
Professional Synonyms:
Congenital ADAMTS-13 deficiency
Upshaw-Schulman syndrome
Indications:
Congenital thrombotic thrombocytopenic purpura
Professional Synonyms:
Congenital ADAMTS-13 deficiency
Upshaw-Schulman syndrome
The following dosing information is available for ADZYNMA (adamts13, recombinant-krhn):
Dosage of ADAMTS13, recombinant-krhn is expressed in IU. The actual ADAMTS13, recombinant-krhn potency in IU is printed on the label of each ADAMTS13, recombinant-krhn vial and carton.
Dosing of ADAMTS13, recombinant-krhn is based on body weight.
Dosing of ADAMTS13, recombinant-krhn is based on body weight.
No enhanced Administration information available for this drug.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| ADZYNMA 500 UNIT VIAL | Maintenance | Adults infuse 40 unit/kg by intravenous route every 2 weeks |
| ADZYNMA 1,500 UNIT VIAL | Maintenance | Adults infuse 40 unit/kg by intravenous route every 2 weeks |
| ADZYNMA 500 UNIT KIT | Maintenance | Adults infuse 40 unit/kg by intravenous route every 2 weeks |
| ADZYNMA 1,500 UNIT KIT | Maintenance | Adults infuse 40 unit/kg by intravenous route every 2 weeks |
No generic dosing information available.
The following drug interaction information is available for ADZYNMA (adamts13, recombinant-krhn):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for ADZYNMA (adamts13, recombinant-krhn):
Drug contraindication overview.
*History of life threatening hypersensitivity reactions to ADAMTS13, recombinant-krhn or its components.
*History of life threatening hypersensitivity reactions to ADAMTS13, recombinant-krhn or its components.
There are 0 contraindications.
There are 0 severe contraindications.
There are 1 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| No disease contraindications |
The following adverse reaction information is available for ADZYNMA (adamts13, recombinant-krhn):
Adverse reaction overview.
The most common adverse reactions (>5%) reported with ADAMTS13, recombinant-krhn in clinical studies were headache, diarrhea, migraine, abdominal pain, nausea, upper respiratory tract infection, dizziness, and vomiting.
The most common adverse reactions (>5%) reported with ADAMTS13, recombinant-krhn in clinical studies were headache, diarrhea, migraine, abdominal pain, nausea, upper respiratory tract infection, dizziness, and vomiting.
There are 1 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Anaphylaxis |
| Rare/Very Rare |
|---|
| None. |
There are 8 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Acute abdominal pain Diarrhea Dizziness Headache disorder Migraine Nausea Upper respiratory infection Vomiting |
None. |
| Rare/Very Rare |
|---|
| None. |
The following precautions are available for ADZYNMA (adamts13, recombinant-krhn):
The safety and effectiveness of ADAMTS13, recombinant-krhn have been established in pediatric patients. Clinical trials included patients 2 years of age and older. Based on results from a population pharmacokinetics analysis, no dosage adjustment is required for pediatric patients. The recommended body weight-based dosing regimen in pediatric patients is the same as that in adults.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
There are no adequate data regarding the use of ADAMTS13, recombinant-krhn in pregnant women. In clinical studies, 4 patients were exposed to ADAMTS13, recombinant-krhn during pregnancy. One patient experienced a miscarriage that was found to be unrelated to ADAMTS13, recombinant-krhn, 2 patients delivered healthy babies with no safety concerns, and one patient delivered at week 29 with no adverse events believed to be due to ADAMTS13, recombinant-krhn.
ADAMTS13, recombinant-krhn administered in female rats at 80, 200, or 400 international units (IU)/kg every third day from 2 weeks before mating through day 16 of gestation was not associated with any adverse maternal findings or treatment-related effects on embryo-fetal development. The decision whether ADAMTS13, recombinant-krhn should be used in pregnancy should balance the potential benefits with risks.
ADAMTS13, recombinant-krhn administered in female rats at 80, 200, or 400 international units (IU)/kg every third day from 2 weeks before mating through day 16 of gestation was not associated with any adverse maternal findings or treatment-related effects on embryo-fetal development. The decision whether ADAMTS13, recombinant-krhn should be used in pregnancy should balance the potential benefits with risks.
It is not known whether ADAMTS13, recombinant-krhn is distributed into human milk, or if the drug has any effects on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ADAMTS13, recombinant-krhn and any potential adverse effects to the breastfed child.
Clinical studies of ADAMTS13, recombinant-krhn did not include patients 65 years of age and older to determine whether they respond differently from younger patients. No dosage adjustment is required for elderly patients based on results from a population pharmacokinetic analysis.
The following prioritized warning is available for ADZYNMA (adamts13, recombinant-krhn):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for ADZYNMA (adamts13, recombinant-krhn)'s list of indications:
| Congenital thrombotic thrombocytopenic purpura | |
| D69.42 | Congenital and hereditary thrombocytopenia purpura |
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