Medicinal Products

ENTRESTO 49 mg / 51 mg

Generic drug of the therapeutic class: Cardiology and angiology
active ingredients: Valsartan + sacubitril
laboratory: Novartis Pharma SA

Coated tablet
box of 4 pads of 14
All forms

Indication

Entresto is indicated in adult patients for the treatment of symptomatic chronic heart failure with reduced ejection fraction (see section 5.1 ).

Dosage ENTRESTO 49 mg / 51 mg film-coated tablet box of 4 tablets of 14

Entresto is indicated in adult patients for the treatment of symptomatic chronic heart failure with reduced ejection fraction (see section 5.1 ).

Against indications

• Hypersensitivity to the active substances, or to any of the excipients listed under Composition .

• Concomitant use of ACE inhibitors (see Warnings and Precautions and Interactions with other medicinal products and other forms of interaction ) sections. Entresto should only be administered 36 hours after stopping the IEC.

• History of angioedema associated with previous treatment with ACEI or ARB II (see Warnings and Precautions section)
of employment ).

• Hereditary or idiopathic angioedema (see section Warnings and precautions for use )

• Concomitant use of aliskiren-containing medicinal products in patients with diabetes or renal impairment (eGFR <60 ml / min / 1.73 m 2 ) (see Warnings and Precautions for Use and Interactions with other drugs and other forms of interaction ).

• Severe hepatic insufficiency, biliary cirrhosis or cholestasis (see section 4.2 ).

• Second and third trimesters of pregnancy (see section on Pregnancy and lactation ).

Entresto side effects

Tolerance Profile Summary

The most common side effects reported during treatment with Entresto were hypotension, hyperkalemia and impaired renal function (see Warnings and Precautions ). Angioedema has been reported in patients treated with Entresto (see description of specific adverse events).

The safety of Entresto in patients with chronic heart failure was assessed in the pivotal phase III study PARADIGM-HF, which compared patients treated with Entresto 97 mg / 103 mg twice daily (n = 4). 203) to enalapril 10 mg twice daily (n = 4229). Randomized patients in the Entresto group were treated for a median of 24 months; 271 patients were treated for more than one year.

In the PARADIGM-HF study, patients were previously treated with ACE inhibitors and / or AIIRAs and had to complete sequential screening periods with enalapril and Entresto (mean duration of exposure of 15 and 29 days, respectively) prior to be randomized into the double-blind treatment period. During the prescribing period with enalapril, 1, 102 patients (10.5%) discontinued the study permanently, including 5.6% due to the occurrence of an adverse event, the most common of which was renal dysfunction. (1.7%), hyperkalemia (1.7%) and hypotension (1.4%). During the preselection period with Entresto, 10.4% of patients definitively discontinued whose study, 5.9% due to the occurrence of an adverse event, the most common of which were renal dysfunction (1.8% ), hypotension (1.7%) and hyperkalemia (1.3%). Due to study outages during the pre-screening period, the frequencies of adverse events presented in the table below may be lower than the frequencies of adverse events expected in clinical practice.

During the double-blind treatment period, treatment was discontinued due to an adverse event in 450 (10.7%) patients treated with Entresto and 516 (12.2%) patients treated with enalapril.

Table of adverse effects

Adverse reactions are classified according to the organ classification system and within each class in descending order of frequency, according to the following convention: very common (≥ 1/10), common (≥ 1/100, <1/10), uncommon (≥ 1/1000, <1/100), rare (≥ 1/10 000, <1/1000), very rare (<1 / 10, 000). In each frequency category, adverse effects are ranked in order of decreasing severity.

Table 1 List of Adverse Reactions in Clinical Studies

Class of organ systems

Preferred term

Frequency

Blood and lymphatic system disorders

Anemia

Frequent

Immune system disorders

hypersensitivity

Rare

Metabolism and nutrition disorders

hyperkalemia *

Very common

hypokalemia

Frequent

hypoglycemia

Frequent

Nervous system disorders

Dizzying sensation

Frequent

cephalalgia

Frequent

Syncope

Frequent

Dizziness postural feeling

Rare

Affections of the ear and

labyrinth

Fear of heights

Frequent

Vascular disorders

hypotension *

Very common

Orthostatic hypotension

Frequent

Respiratory disorders,

thoracic and mediastinal

Cough

Frequent

Gastrointestinal disorders

Diarrhea

Frequent

nausea

Frequent

Gastritis

Frequent

Skin and subcutaneous tissue disorders

itching

Rare

rash

Rare

angioedema *

Rare

Renal and urinary disorders

Alteration of renal function *

Very common

Renal insufficiency (renal failure, acute renal failure)

Frequent

General disorders and administration site conditions

Tired

Frequent

Asthenia

Frequent

* See description of specific side effects.

Description of specific adverse events

angioedema

Cases of angioedema have been reported in patients treated with Entresto. In PARADIGM-HF, angioedema was reported in 0.5% of Entresto-treated patients compared to 0.2% of enalapril-treated patients. A higher incidence of angioedema was observed in black patients treated with Entresto (2.4%) and enalapril (0.5%) (see Warnings and Precautions ).

Hyperkalemia and potassium

In the PARADIGM-HF study, hyperkalemia and serum potassium> 5.4 mmol / l were reported in 11.6% and 19.7% of patients treated with Entresto and in 14.0% and 21.1% of patients treated with enalapril, respectively.

Arterial pressure

In PARADIGM-HF, hypotension and clinically significant decreases in systolic blood pressure (20 mmHg) were reported in 17.6% and 4.76% of Entresto-treated patients compared to 11.9% and 2.67%, respectively. % of patients treated with enalapril, respectively.

Renal failure

In PARADIGM-HF, impaired renal function was reported in 10.1% of Entresto-treated patients and 11.5% of enalapril-treated patients.

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals report any suspected adverse reactions via the national reporting system - see Annex V.

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