For your African American patients with heart failure (HF) there is no substitute for BiDil

FDA has confirmed there are no generic or therapeutic equivalents for BiDil¹⁵

• The Isordil® (ISDN) and specialty hydralazine HCl formulations used in V-HeFT I and II* are NOT bioequivalent to BiDil¹⁶

The plasma concentrations of Isordil tablets and specialty hydralazine HCl tablets are lower than those of the ISDN and hydralazine HCI in BiDil.¹⁶

Both the Cmax‡ and AUC† of the Isordil and specialty hydralazine HCl used in V-HeFT I and II*, when used at identical mg doses as BiDil, were not within the FDA-specified range and are not considered to be bioequivalent to BiDil¹⁶

There are No Generic Equivalents for BiDil - The Evidence
This slide deck highlights the differences between BiDil vs. ISDN and hydralazine.

* Veterans Administration Cooperative Vasodilator-Heart Failure Trial.
‡ C_max is the maximum plasma concentration or level of the drug in the body.
† AUC or area under the curve is the total amount of the drug absorbed by the body.
§ t_1/2 or half-life is the amount of time required for the amount of drug in the body to be reduced by half.

Important information about BiDil®
(isosorbide dinitrate/hydralazine hydrochloride):

INDICATIONS AND USAGE
BiDil is indicated for the treatment of heart failure as an adjunct to standard therapy in self-identified black patients to improve survival, to prolong time to hospitalization for heart failure, and to improve patient reported functional status. There is little experience in patients with NYHA class IV heart failure. Most patients in the clinical trial supporting effectiveness (A-HeFT) received a loop diuretic, an angiotensin converting enzyme inhibitor or an angiotensin II receptor blocker, and a beta blocker, and many also received a cardiac glycoside or an aldosterone antagonist.

CONTRAINDICATIONS
BiDil is contraindicated in patients who are allergic to organic nitrates.

WARNINGS
Augmentation of the vasodilatory effects of isosorbide dinitrate by phosphodiesterase inhibitors such as sildenafil, vardenafil, or tadalafil could result in severe hypotension. The time course and dose dependence of this interaction have not been studied. Reasonable supportive care should consist of those measures used to treat a nitrate overdose with elevation of the extremities and central volume expansion.

ADVERSE REACTIONS
Adverse events reported in A-HeFT and seen more frequently in the group given BiDil included headache (50% in BiDil patients vs. 21% in placebo patients) and dizziness (32% in BiDil patients vs. 14% in placebo patients).

The full Prescribing Information for BiDil is available here.