Hemostan Side effects

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• Side effects of Hemostan in details
• Hemostan contraindications
• Hemostan reviews

What are the possible side effects of Hemostan?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using Hemostan and call your doctor at once if you have a serious side effect such as:

• problems with your vision (including color vision);

• sudden numbness or weakness, especially on one side of the body;

• sudden severe headache, confusion, problems with vision, speech, or balance;

• chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;

• pain, swelling, warmth, or redness in one or both legs;

• seizure (convulsions);

• painful or difficult urination;

• blood in your urine; or

• feeling like you might pass out.

Less serious side effects include:

• nausea, vomiting, diarrhea;

• mild itching or rash; or

• feeling unusually happy.

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.

Side effects of Hemostan in details

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Short-term Studies

The safety of Hemostan Tablets in the treatment of heavy menstrual bleeding (HMB) was studied in two randomized, double-blind, placebo-controlled studies. One study compared the effects of two doses of Hemostan Tablets (1950 mg and 3900 mg given daily for up to 5 days during each menstrual period) versus placebo over a 3-cycle treatment duration. A total of 304 women were randomized to this study, with 115 receiving at least one dose of 3900 mg/day of Hemostan Tablets. A second study compared the effects of Hemostan Tablets (3900 mg/day) versus placebo over a 6-cycle treatment duration. A total of 196 women were randomized to this study, with 117 receiving at least one dose of Hemostan Tablets. In both studies, subjects were generally healthy women who had menstrual blood loss of ≥ 80 mL.

In these studies, subjects were 18 to 49 years of age with a mean age of approximately 40 years, had cyclic menses every 21-35 days, and a BMI of approximately 32 kg/m2. On average, subjects had a history of HMB for approximately 10 years and 40% had fibroids as determined by transvaginal ultrasound. Approximately 70% were Caucasian, 25% were Black, and 5% were Asian, Native American, Pacific Islander, or Other. Seven percent (7%) of all subjects were of Hispanic origin. Women using hormonal contraception were excluded from the trials.

The rates of discontinuation due to adverse events during the two clinical trials were comparable between Hemostan Tablets and placebo. In the 3-cycle study, the rate in the 3900 mg Hemostan Tablets dose group was 0.8% as compared to 1.4% in the placebo group. In the 6-cycle study, the rate in the Hemostan Tablets group was 2.4% as compared to 4.1% in the placebo group. Across the studies, the combined exposure to 3900 mg/day Hemostan Tablets was 947 cycles and the average duration of use was 3.4 days per cycle.

A list of adverse events occurring in ≥ 5% of subjects and more frequently in Hemostan Tablets treated subjects receiving 3900 mg/day compared to placebo is provided in Table 2.

Long-term Studies

Long-term safety of Hemostan Tablets was studied in two open-label studies. In one study, subjects with physician-diagnosed heavy menstrual bleeding (not using the alkaline hematin methodology) were treated with 3900 mg/day for up to 5 days during each menstrual period for up to 27 menstrual cycles. A total of 781 subjects were enrolled and 239 completed the study through 27 menstrual cycles. A total of 12.4% of the subjects withdrew due to adverse events. Women using hormonal contraception were excluded from the study. The total exposure in this study to 3900 mg/day Hemostan Tablets was 10,213 cycles. The average duration of Hemostan Tablets use was 2.9 days per cycle.

A long-term open-label extension study of subjects from the two short-term efficacy studies was also conducted in which subjects were treated with 3900 mg/day for up to 5 days during each menstrual period of up to 9 menstrual cycles. A total of 288 subjects were enrolled and 19% subjects completed the study through 9 menstrual cycles. A total of 2.1% of the subjects withdrew due to adverse events. The total exposure to 3900 mg/day Hemostan Tablets in this study was 1,956 cycles. The average duration of Hemostan Tablets use was 3.5 days per cycle.

The types and severity of adverse events in these two long-term open-label trials were similar to those observed in the double-blind, placebo-controlled studies although the percentage of subjects reporting them was greater in the 27-month study, most likely because of the longer study duration.

A case of severe allergic reaction to Hemostan Tablets was reported in the extension trial, involving a subject on her fourth cycle of treatment, who experienced dyspnea, tightening of her throat, and facial flushing that required emergency medical treatment.

Postmarketing Experience

The following adverse reactions have been identified from postmarketing experience with Hemostan. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Based on US and worldwide postmarketing reports, the following have been reported in patients receiving Hemostan for various

Indications:

• Nausea, vomiting, and diarrhea
• Allergic skin reactions
• Anaphylactic shock and anaphylactoid reactions
• Thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, cerebral thrombosis, acute renal cortical necrosis, and central retinal artery and vein obstruction); cases have been associated with concomitant use of combination hormonal contraceptives
• Impaired color vision and other visual disturbances
• Dizziness

What is the most important information I should know about Hemostan?

• Hemostan may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Hemostan with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• If your symptoms do not get better after 2 menstrual cycles, if they get worse, or if Hemostan seems to stop working, check with your doctor.
• If you notice an unusual change in your bleeding pattern, check with your doctor.
• The risk of a stroke, a heart attack, or other blood clots may be increased when Hemostan is used with hormonal birth control (eg, birth control pills). The risk may be greater if you are very overweight or if you smoke cigarettes, especially if you are older than 35 years old. Discuss any questions or concerns with your doctor.
• Tell your doctor or dentist that you take Hemostan before you receive any medical or dental care, emergency care, or surgery.
• Lab tests, including eye exams, may be performed while you use Hemostan. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Hemostan should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
• Use Hemostan with caution in the ELDERLY; they may be more sensitive to its effects.
• Hemostan is not indicated in women who have been through menopause or in children who have not had their first menstrual period. Discuss any questions or concerns with your doctor.
• PREGNANCY and BREAST-FEEDING: Hemostan is not approved for use in pregnant women. If you become pregnant while taking Hemostan, contact your doctor. Hemostan is found in breast milk. If you are or will be breast-feeding while you take Hemostan, check with your doctor or pharmacist. Discuss any possible risks to your baby.

Hemostan contraindications

Thromboembolic Risk

​Do not prescribe Hemostan Tablets to women who are

• ​using combination hormonal contraception
• ​known to have any of the following conditions:
  • Active thromboembolic disease (e.g., deep vein thrombosis, pulmonary embolism, or cerebral thrombosis)
  • A history of thrombosis or thromboembolism, including retinal vein or artery occlusion
  • An intrinsic risk of thrombosis or thromboembolism (e.g., thrombogenic valvular disease, thrombogenic cardiac rhythm disease, or hypercoagulopathy)

Venous and arterial thrombosis or thromboembolism, as well as cases of retinal artery and retinal vein occlusions, have been reported with Hemostan.

Hypersensitivity to Hemostan

Do not prescribe Hemostan Tablets to women with known hypersensitivity to Hemostan.

References

1. DailyMed. "TRANEXAMIC ACID: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. DTP/NCI. "tranexamic acid: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
3. European Chemicals Agency - ECHA. "Tranexamic acid: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology