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AbbVie Limited

Citywest Business Campus, Dublin 24, Ireland
Telephone: +353 1 428 7900
Fax: +353 1 428 7940
Summary of Product Characteristics last updated on medicines.ie: 20/07/2017
SPC Norvir 100 mg powder for oral suspension

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 20/07/2017 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   13-Jul-2017
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company



Section 4.6 - Fertility, pregnancy and lactation

 

The following information has been updated as follows:

 

Was:

Pregnancy

A limited number (> 800) of pregnant women were exposed to ritonavir during pregnancy; a very limited number (< 300) were exposed during the first trimester.  These data largely refer to exposures where ritonavir was used in combination therapy and not at therapeutic ritonavir doses but at lower doses as a pharmacokinetic enhancer for other PIs.  These limited data indicate no increase in the rate of birth defects compared to rates observed in population-based birth defect surveillance systems.  Animal data have shown reproductive toxicity (see 5.3).  The use of Norvir may be considered in pregnancy only when the benefits outweigh the risk to the foetus.

 

Ritonavir adversely interacts with oral contraceptives (OCs).  Therefore, an alternative, effective and safe method of contraception should be used during treatment.

 

Breastfeeding

It is not known whether this medicine is excreted in human milk.  Milk excretion has not been measured in the animal studies, however a study in rats showed some effects on offspring development during lactation which are compatible with excretion of ritonavir in milk in that species.  HIV infected women should not breast-feed their infants under any circumstances to avoid transmission of HIV. 

 

Updated to:

Pregnancy

A large amount (6100 live births) of pregnant women were exposed to ritonavir during pregnancy; of these, 2800 live births were exposed during the first trimester.  These data largely refer to exposures where ritonavir was used in combination therapy and not at therapeutic ritonavir doses but at lower doses as a pharmacokinetic enhancer for other PIs.  These data indicate no increase in the rate of birth defects compared to rates observed in population-based birth defect surveillance systems.  Animal data have shown reproductive toxicity (see 5.3).  Norvir can be used during pregnancy if clinically needed.

 

Ritonavir adversely interacts with oral contraceptives (OCs).  Therefore, an alternative, effective and safe method of contraception should be used during treatment.

 

Breastfeeding

Limited published data reports that ritonavir is present in human milk.

 

There is no information on the effects of ritonavir on the breastfed infant or the effects of the drug on milk production.  Because of the potential for (1) HIV transmission (in HIV-negative infants), (2) developing viral resistance (in HIV-postive infants) and (3) serious adverse reactions in a breastfed infant,  HIV infected women should not breast feed their infants under any circumstances if they are receiving Norvir. 

 

Section 10 - Date of Revision of the Text

 

Changed to 13 July 17

 

 

Updated on 15/06/2017 and displayed until 20/07/2017
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   02-Jun-2017
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company



Section 4.3 - Contraindications

·         The list of medicinal products which Norvir should not be co-administered with has been updated to include

o    Ranolazine (medical product class: antianginal)
Rationale: Increased plasma concentrations of ranolazine which may increase the potential for serious and/or life-threatening reactions (see section 4.5).

o    Lurasidone (medical product class: Antipsychotics/ Neuroleptics)
Rationale: Increased plasma concentrations of lurasidone which may increase the potential for serious and/or life-threatening reactions (see section 4.5).



Section 4.5 -  Interaction with other medicinal products and other forms of interaction

 

·    The following medicinal products have been added to the Interaction table:

o    Ranolazine (Due to CYP3A inhibition by ritonavir, concentrations of ranolazine are expected to increase.  The concomitant administration with ranolazine is contraindicated (see section 4.3).)

o    Lurasidone (Due to CYP3A inhibition by ritonavir, concentrations of lurasidone are expected to increase.  The concomitant administration with lurasidone is contraindicated (see section 4.3).)

·    Information relating to Fluticasone propionate aqueous spray has been updated to read:

Inhaled, injectable or intranasal fluticasone propionate, budesonide, triamcinolone

Systemic corticosteroid effects including Cushing's syndrome and adrenal suppression (plasma cortisol levels were noted to be decreased 86% in the above study) have been reported in patients receiving ritonavir and inhaled or intranasal fluticasone propionate; similar effects could also occur with other corticosteroids metabolised by CYP3A e.g., budesonide and triamcinolone.  Consequently, concomitant administration of ritonavir dosed as an antiretroviral agent or as a pharmacokinetic enhancer and these glucocorticoids is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects (see section 4.4).  A dose reduction of the glucocorticoid should be considered with close monitoring of local and systemic effects or a switch to a glucocorticoid, which is not a substrate for CYP3A4 (e.g., beclomethasone).  Moreover, in case of withdrawal of glucocorticoids progressive dose reduction may be required over a longer period.   

 

 

 

 

Section 10 – Date of Revision of Text

 

·    Updated to 02 June 2017

Updated on 27/09/2016 and displayed until 15/06/2017
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   15-Sep-2016
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company



 4.4      Special warnings and precautions for use

 

The following warning has been added:

Riociguat

The concomitant use of ritonavir is not recommended due to potiential increase in riociguat exposure (see section 4.5).

 

Vorapaxar

The concomitant use of ritonavir is not recommended due to potential increase in vorapaxar exposure (see section 4.5).



 

 

4.5          Interaction with other medicinal products and other forms of interaction

The following interactions have been added:

 

Afatinib

20 mg, single dose

40 mg, single dose

40 mg, single dose

200 q12h/1h before

200 q12h/ co-administered

200 q12h/6h after

↑ 48%

 

↑ 19%

 

↑ 11%

↑ 39%

 

↑ 4%

 

↑ 5%

Serum concentrations may be increased due to Breast Cancer Resistance Protein (BCRP) and acute P‑gp inhibition by ritonavir.  The extent of increase in AUC and Cmax depends on the timing of ritonavir administration.  Caution should be exercised in administering afatinib with Norvir (refer to the afatinib SmPC).  Monitor for ADRs related to afatinib.

 

Ceritinib

Serum concentrations may be increased due to CYP3A and P‑gp inhibition by ritonavir.  Caution should be exercised in administering ceritinib with Norvir.  Refer to the ceritinib SmPC for dosage adjustment recommendations.  Monitor for ADRs related to ceritinib.

Vorapaxar

Serum concentrations may be increased due to CYP3A inhibition by ritonavir.  Coadministration of vorapaxar and Norvir should be avoided (refer to the vorapaxar SmPC).

Riociguat

Serum concentrations may be increased due to CYP3A and P-gp inhibition by ritonavir.  The coadministration of riociguat with Norvir is not recommended (see section 4.4 and refer to riociguat SmPC).

 

 

 

Updated on 14/07/2016 and displayed until 27/09/2016
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

None provided

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Active Ingredients

 
   Ritonavir