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CYKLOKAPRON®Highlights (tranexamic acid)

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use CYKLOKAPRON safely and effectively. See full prescribing information for CYKLOKAPRON.

CYKLOKAPRON® (tranexamic acid) injection, for intravenous use
Initial U.S. Approval: 1986

INDICATIONS AND USAGE

CYKLOKAPRON is an antifibrinolytic indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction. (1)

DOSAGE AND ADMINISTRATION

  • Before Extraction: Administer 10 mg/kg actual body weight of CYKLOKAPRON intravenously with replacement therapy. (2.1)
  • After Extraction: Administer 10 mg/kg actual body weight 3 to 4 times daily for 2 to 8 days. Infuse no more than 1 mL/minute to avoid hypotension. (2.1).
  • Reduce the dosage for patients with renal impairment. (2.2, 8.6)

DOSAGE FORMS AND STRENGTHS

  • Injection: 1000 mg tranexamic acid (100 mg/mL) in 10 mL single-dose ampules (3)
  • Injection: 1000 mg tranexamic acid (100 mg/mL) in 10 mL single-dose vials (3)

CONTRAINDICATIONS

  • In patients with subarachnoid hemorrhage, due to risk of cerebral edema and cerebral infarction. (4)
  • In patients with active intravascular clotting. (4)
  • In patients with severe hypersensitivity reactions to tranexamic acid or any of the ingredients. (4)

WARNINGS AND PRECAUTIONS

  • Risk of Thrombosis with Concomitant Use of Factor IX: Avoid concomitant use. (5.1)
  • Seizures: Inadvertent injection into neuraxial system may result in seizures. (5.2)
  • Hypersensitivity Reactions: In case of severe reaction, discontinue use and seek immediate medical attention. (5.3)
  • Visual Disturbances: Visual or ocular adverse effects may occur. Discontinue use if visual or ocular symptoms occur. (5.4)
  • Dizziness: Advise patients not to drive if dizziness occurs (5.5).

ADVERSE REACTIONS

Most common adverse reactions are nausea, vomiting, diarrhea, allergic dermatitis, giddiness, hypotension, and thromboembolic events. (6)


To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Prothrombotic Medical Products: Avoid concomitant use, can further increase the risk of thromboembolic adverse reactions associated with tranexamic acid. (5.1, 7.1, 8.3)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 6/2020

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Report Adverse Event

Contact Pfizer Safety to report an adverse event, side effect or concern about the quality of a Pfizer product: (800) 438-1985

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns at 1-800-FDA-1088 or www.fda.gov/MedWatch