Pretomanid vs. Sirturo

Pretomanid was approved by the FDA as part of a combination regimen with bedaquiline (Sirturo) and linezolid for the treatment of adults with pulmonary extensively drug-resistant tuberculosis (XDR-TB) or treatment non-responsive or intolerant MDR-TB. Separately, bedaquiline (Sirturo) is also FDA approved as part of combination therapy (background regimen) for the treatment of adult (≥ 18 years old) and pediatric patients (12 to less than 18 years of age and weighing at least 30 kg) with pulmonary MDR-TB.

Side effects of pretomanid and Sirturo that are similar include nausea, headache, increased transaminases, rash, chest pain, coughing up blood, and anorexia.

Side effects of pretomanid that are different from Sirturo include numbness and tingling of extremities, acne, anemia, vomiting, indigestion, decreased appetite, itching, abdominal pain, increased gamma-glutamyltransferases, lower respiratory tract infection, excess amylase in the blood, back pain, cough, visual impairment, low blood sugar (hypoglycemia), and diarrhea.

Side effects of Sirturo that are different from pretomanid include joint pain and increased blood amylase.

Both pretomanid and Sirturo may interact with rifamycins.

Pretomanid may also interact with strong or moderate CYP3A4 inducers and organic anion transporter-3 (OAT3) substrates.

Sirturo may also interact with azole antifungals, lopinavir/ritonavir, efavirenz, and clofazimine.

Common side effects of Pretomanid include:

• numbness and tingling of extremities, acne,
• anemia,
• nausea,
• vomiting,
• headache,
• increased transaminases,
• indigestion,
• decreased appetite,
• rash,
• itching,
• abdominal pain,
• sharp chest pain during breathing,
• increased gamma-glutamyltransferases,
• lower respiratory tract infection,
• excess amylase in the blood,
• coughing up blood,
• back pain,
• cough,
• visual impairment,
• low blood sugar (hypoglycemia),
• abnormal weight loss, and
• diarrhea

Side effects of Sirturo nclude<:/p>

• nausea
• joint pain
• headache
• coughing up blood
• chest pain
• anorexia
• rash
• increased transaminases and blood amylase

Abdominal pain is a possible side effect among pediatric patients.

Pretomanid is an antimycobacterial indicated, as part of a combination regimen with bedaquiline and linezolid, for the treatment of adults with pulmonary extensively drug resistant (XDR) treatment-intolerant or nonresponsive multidrug-resistant (MDR) tuberculosis (TB). Pretomanid is indicated for use in a limited and specific population of patients.

Sirturo (bedaquiline) is a a diarylquinoline antimycobacterial drug used to treat adults with pulmonary multi-drug resistant tuberculosis (MDR-TB) when other alternatives are not available. Sirturo is the first drug approved to treat multi-drug resistant TB and should be used in combination with other drugs used to treat TB.

Pretomanid may interact with strong or moderate CYP3A4 inducers (such as rifampin or efavirenz) and organic anion transporter-3 (OAT3) substrates. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Pretomanid; it is unknown how it would affect a fetus. There are risks associated with active tuberculosis during pregnancy. It is unknown if Pretomanid passes into breast milk. Because of the potential for adverse reactions in nursing infants, breastfeeding is not recommended while using Pretomanid.

Sirturo may interact with rifamycins, azole antifungals, lopinavir/ritonavir, efavirenz, and clofazimine. Tell your doctor all medications and supplements you use. Before taking Situro, women should tell their healthcare providers if they are pregnant or planning to become pregrnant; or breastfeeding or planning to breastfeed. It is not known if Sirturo passes into breast milk. Patients and their healthcare providers should decide if the patient will take Sirturo or breastfeed. Patients should not do both.

Pretomanid Tablets must be administered only as part of a regimen in combination with bedaquiline and linezolid. The dose of Pretomanid Tablets is 200 mg orally once daily for 26 weeks; along with bedaquiline 400 mg orally once daily for 2 weeks followed by 200 mg 3 times per week, with at least 48 hours between doses, for 24 weeks for a total of 26 weeks; and 1,200 mg linezolid daily orally for up to 26 weeks.

The recommended dose for Sirturo is 400 mg once daily for 2 weeks followed by 200 mg 3 times per week for 22 weeks with food. Sirturo tablets should be swallowed whole with water.