Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Rifabutin

Generic name
Rifabutin
Brand name
ATC Code
J04AB04

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

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

No information is present at this moment.

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Available formulations

No information is present at this moment.

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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.

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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.

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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.

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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.

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Interactions

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

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

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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

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Changes

Changes