Rifabutin

Generic name
Rifabutin
Brand name
ATC Code
J04AB04
Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

The following kinetic parameters have been found in 6 HIV-infected children (0.8-3.4 years) who also use ritonavir and lopinavir (Siberry 2013):

Dose3x/week 5 mg, 6 doses
Cmax 0.39 µg/mL
Tmax 3 hours
t½ 16 hours

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Prophylaxis for Mycobacterium avium complex (MAC) infection in HIV infection or HIV exposure
  • Oral
    • 1 month up to 18 years
      • There is little literature available about the use of rifabutin as prophylaxis against MAC infections. An American guideline gives the following recommendations: 5 mg/kg/day in 1 dose. Max: 300 mg/day.
        • Adjust the dose when combined with protease inhibitors and NNRTIs; watch out for interactions.
        • Treatment by or after consulting a paediatrician/infectiologist who has experience of using rifabutin for this indication.
    • 1 month up to 18 years
      [7]
      • There is little literature available about the use of rifabutin as prophylaxis against MAC infections. An American guideline gives the following recommendations: 5 mg/kg/day in 1 dose. Max: 300 mg/day.
        • Adjust the dose when combined with protease inhibitors and NNRTIs; watch out for interactions.
        • Treatment by or after consulting a paediatrician/infectiologist who has experience of using rifabutin for this indication.

Renal impaiment in children > 3 months

Adjustment in renal impairment as specified:

GFR 50-80 ml/min/1.73 m2
Adjustment is not required
GFR 30-50 ml/min/1.73 m2
Adjustment is not required
GFR 10-30 ml/min/1.73 m2
50 percentage of single dose and dosing interval : 24 uur
GFR < 10 ml/min/1.73 m2
Generalized recommendations cannot be given.

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

Deposits in the cornea, uveitis, discolouration of urine, sputum, skin and tear fluid. Nausea, vomiting, diarrhoea, increased liver enzymes, leukopenia, neutropenia and thrombocytopenia.

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

Rifabutin should be administered as part of a combination treatment. It is recommended that there should be regular checks of the white blood cells, blood platelets and liver enzymes during the treatment.

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

DRUGS FOR TREATMENT OF TUBERCULOSIS

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Antibiotics
J04AB02
Hydrazides
J04AC01
Other drugs for treatment of tuberculosis
J04AK05
J04AK06
J04AK02
J04AK01

References

  1. Rademaker C.M.A. et al, Geneesmiddelen Formularium voor Kinderen, 2007
  2. Dunn AM, et al, Rifabutin-associated uveitis in a pediatric patient., Pediatr Infect Dis J, 1995, 14, 246-7
  3. Olesen HH, et al, Rifabutin-associated uveitis in a child, Pediatr Infect Dis J, 2005, 24, 1023-5
  4. Smith JA, et al, Corneal endothelial deposits in children positive for human immunodeficiency virus receiving rifabutin prophylaxis for Mycobacterium avium complex bacteremia, Am J Ophthalmol., 1999, 127, 164-9
  5. Jewelewicz DA, et al, Rifabutin-associated uveitis in an immunosuppressed pediatric patient without acquired immunodeficiency syndrome, Am J Ophthalmol, 1998, 125, 872-3
  6. Moultrie H et al. 2015 , Pharmacokinetics and safety of rifabutin in young HIV-infected children receiving rifabutin and lopinavir/ritonavir. , J Antimicrob Chemother., 2015, Feb;70(2), 543-9
  7. Siberry GK et al., Guidelines for the prevention and treatment of opportunistic infections in HIV-exposed and HIV-infected children: recommendations from <......>, Pediatr Infect Dis J., 2013, Nov;32, Suppl 2:i-KK4
  8. Moultrie H et al. 2015, Pharmacokinetics and safety of rifabutin in young HIV-infected children receiving rifabutin and lopinavir/ritonavir., J Antimicrob Chemother., 2015, Feb;70(2), 543-9

Changes

Therapeutic Drug Monitoring


Overdose