Darunavir Side Effects

Serious Adverse Side Effects

Darunavir has some very serious adverse side effects associated with it, such as:

Dermatological side effects like acute generalized exanthematous pustulosis, a severe skin reaction, other skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis
Endocrine metabolic side effects like diabetes mellitus
Gastrointestinal side effects like pancreatitis, or inflammation of the pancreas
Hepatic side effects like hepatitis

Common Adverse Side Effects

Darunavir has some more common and less severe adverse side effects associated with it, such as:

Dermatological side effects like rash
Endocrine metabolic side effects like increase in triglycerides and increase in cholesterol
Gastrointestinal side effects like abdominal pain, diarrhea, nausea, and vomiting
Neurological side effects like headaches

Warnings & Recalls for Darunavir

Contraindications

The contraindications of Darunavir include:

Concurrent use with agents highly dependent upon CYP3A for clearance and for having a narrow therapeutic index. These include: alfuzosin, cisapride, dihydroergotamine, lovastatin, methylergonovine, oral midazolam, pimozide, rifampin, simvastatin, St. John’s wort, and triazolam
Concurrent use with sildenafil for treating pulmonary arterial hypertension

Who Should Not Take This Drug

Darunavir should never be taken by patients with these preexisting conditions:

Autoimmune disorders
Patients who take saquinavir, lopinavir/ritonavir, boceprevir, telaprevir, or salmeterol
Patients who take other protease inhibitors other than ritonavir, atazanavir, or indinavir
Patients with diabetes mellitus
Patients with type A or B hemophilia
Patients with hepatic impairments
Patients with preexisting liver dysfunctions
Pediatric patients younger than the age of 3
Patients prone to skin reactions
Patients with sulfonamide allergies

Pregnancy Warning

Darunavir has a pregnancy category rating of “C” by the FDA, implying that it is unknown to pose a risk to the fetus, however upon knowledge of conception, it should be discontinued.

Darunavir Treatment and Use

Darunavir | Prezista is a drug that’s prescribed to treat HIV infection. The classification of this drug is that of a protease inhibitor and is an Office of AIDS Research Advisory Council recommended treatment option for both adolescents and adults who might have never had treatment with a regimen of medications, or for patients who have already undergone a series of treatments for handling their HIV.

Darunavir has been developed by Tibotec, which is a subsidiary company of Janssen Research & Development, LLC. It is worth noting that this formulation was discovered the synthesis for Darunavir by a chemist named Arun K. Ghosh at the University of Illinois at Chicago. It was first approved by the FDA on the 23^rd of June in the year 2006.

Darunavir has garnered much praise and attention since the time of its release because it is representative of an important treatment option for patients with previously untreatable strains of HIV. Many patient advocacy groups pressured the developer Tibotec not to follow the trends of other HIV drug manufacturers and marketers by releasing the new drug at prices higher than existing drugs of the same classification. The price of Darunavir was matched to other common protease inhibitors already in circulation, such as fixed-dose combination drugs. Darunavir costs around $9,000 for a supply of one year.

How This Drug Works

Darunavir is a protease inhibitor that prevents the cleavage of Gag and Gag-Pol polyproteins yielding noninfectious and immature viruses of HIV.

Darunavir is a 2^nd-generation protease inhibitor, which are designed specifically to overcome the problems of the older agents of this classification. Early protease inhibitors, or PIs, often have severe adverse side effects and toxicities, are costly to manufacture, often require a high dosage for treatment, and also show a willingness to be susceptible to drug resistant mutations. These mutations associated with the HIV virus can develop in as little as a year of treatment, effectively making the drugs useless. Darunavir was designed to develop robust interactions with the protease enzymes of many different strains of HIV, including the strains which had previously proven to be treatment-resistant due to mutations.

Dosage Information

The recommended oral dosage of Darunavir is about 600mg, which is composed of two 300mg tablets taken twice daily with Ritonavir (100mg) with food.