Adempas Riociguat Application Scope

For the treatment of the following adult patients:

Chronic thromboembolic pulmonary hypertension (CTEPH): For the treatment of persistent or recurrent CTEPH following surgery, or CTEPH in patients who are not candidates for surgery.
Pulmonary arterial hypertension (PAH): Primarily for idiopathic or hereditary PAH, and PAH associated with connective tissue diseases.

adempas riociguat

Adempas Riociguat Characteristics

Ingredients: The main ingredient is riociguat.
Properties: A soluble guanylate cyclase (sGC) agonist. It dilates pulmonary blood vessels by increasing the signalling molecule cGMP within the vessels, thereby lowering blood pressure.
Packaging Specification: 0.5mg / 1mg / 1.5mg / 2mg / 2.5mg per tablet
Storage: Keep sealed and store at a temperature not exceeding 30°C.
Expiry Date: See outer packaging
Executive Standard: See the approved package insert
Approval Number: HJ20170360
Date of Revision: See the latest approved package insert
Manufacturer: Bayer AG

Guidelines for the Use of Adempas

Dosage and Administration:
- Recommended Dose: Treatment should commence at a low dose, with titration over several weeks under medical supervision based on individual tolerance (primarily blood pressure) to determine the optimal dose for each patient. The recommended starting dose is 1mg three times daily. The optimal individualised maintenance dose range is 0.5mg to 2.5mg three times daily.
- Administration: Take orally three times daily, at intervals of six to eight hours.
- Missed Dose: Please consult your prescribing doctor.
Adverse Reactions:
- Common Adverse Reactions: In clinical trials, the more commonly observed adverse reactions included headache, dizziness, indigestion, nausea, diarrhoea, vomiting, and peripheral oedema (such as ankle swelling).
- Serious Adverse Reactions: Although the incidence is low, life-threatening pulmonary haemorrhage or haemoptysis may occur, particularly in patients with risk factors for pulmonary disease.
Contraindications:
- Patients with a known hypersensitivity to riociguat or any component of its formulation.
- Concomitant use with phosphodiesterase-5 inhibitors and any form of nitrates or nitric oxide donors.
- Severe hepatic impairment (Child-Pugh Class C).
- Patients with systolic blood pressure < 95 mmHg at treatment initiation.
- Women who are pregnant, planning to conceive, or breastfeeding.
Precautions:
- Blood pressure monitoring: This product may cause a reduction in blood pressure; blood pressure should be closely monitored during treatment.
- Bleeding risk: There have been reports of severe haemoptysis and pulmonary haemorrhage following administration; caution is advised in patients with a relevant medical history.
- Smoking effects: Smoking reduces the blood concentration of this product, affecting its efficacy. Smoking should be avoided during treatment.

Riociguat Interactions

Nitrate medications: The antihypertensive effect of sublingual nitroglycerin (0.4 mg) is potentiated when administered 4 and 8 hours after the maximum oral dose of riociguat. Therefore, the concomitant use of riociguat with any form of nitrates or nitric oxide donors (such as amyl nitrite) is contraindicated.
PDE-5 inhibitors: Concomitant use of Riociguat with sildenafil or vardenafil results in an additive effect on reducing systolic blood pressure. Therefore, the combined use of Riociguat and PDE-5 inhibitors (such as sildenafil, tadalafil, vardenafil) is contraindicated.
Potent CYP3A4 inhibitors and P-gp inhibitors: such as ketoconazole and ritonavir, may increase riociguat plasma concentrations. Close monitoring is required, and dose reduction should be considered.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.