Norvir 100 mg powder for oral suspension *

  • Company:

    AbbVie Limited
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

When a pharmaceutical company changes any document, 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 05 March 2021

File name

PL_Norvir Pwd for OS_Art61-3_UK-NI_03Mar2021_1614962123.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Addition of marketing authorisation holder
  • Addition of information on reporting a side effect.

Updated on 21 July 2020

File name

PL_Norvir Pwd for OS_WS1845_16Jul20_1595339881.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink

Updated on 21 July 2020

File name

SPC_Norvir Pwd for OS_WS1845_16Jul20_1595339827.pdf

Reasons for updating

  • 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

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.5

Uodate to include information regarding drug drug interaction with fostamatinib

Updated on 15 July 2020

File name

PL_Norvir Pwd Oral Solu _WS1842_02Jul2020_1594823927.pdf

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 15 July 2020

File name

SmPC_Norvir Pwd Oral Solu_WS1842_02Jul2020_1594823802.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update to  section 4.8 Undesirable effects of the SmPCs to add information regarding nephrolithiasis.  

Minor editorial formating changes

Updated on 27 September 2019

File name

SPC_Norvir100mgPOS_WS1677_19Sep19_1569580514.pdf

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 27 September 2019

File name

PL_Norvir100mgPOS_WS1677_19Sep19_1569580439.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink

Updated on 29 July 2019

File name

PL_Norvir100mgPOS_WS1588_29Jul19_1564399390.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink

Updated on 29 July 2019

File name

SPC_Norvir100mgPOS_WS1588_29Jul19_1564399435.pdf

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 09 May 2019

File name

PL_Norvir100mgPOS_WS1555_29Apr19_1557329214.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - interactions with other medicines, food or drink

Updated on 08 May 2019

File name

SPC_Norvir100mgPOS_WS1555_29Apr19_1557329330.pdf

Reasons for 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

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.3 – Contraindications and Section 4.5 - Interaction with other medicinal products and other forms of interaction

  • Updated to include contraindication regarding concomitant use of Norvir with lomitapide.

     

Section 10 - Date of Revision of the Text

  • Updated to 04/2019

Updated on 15 February 2019

File name

PL_NorvirPOS_NOS discont_01Feb19_1550243701.pdf

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 15 February 2019

File name

SPC_NorvirPOS_NOS discont_01Feb19_1550243813.pdf

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.5

Sub-section: Medicinal product that are affected by the use of ritonavir
 

The following statement has been removed:

“Norvir oral solution should not be co-administered with amprenavir oral solution to children due to the risk of toxicity from excipients in the two formulations”
 

Section 5.2

The following statement has been removed (underneath Ritonavir Dosing Regimen table)

“Ritonavir AUC and Cmax after administration of a single 100 mg dose powder for oral suspension are bioequivalent to the 100 mg oral solution under fed conditions.”

 

Section 10

Sate of Revision amended to 01 February 2019

Updated on 12 November 2018

File name

SPC_NorvirPwdSusp_WS1486_25Oct18_1542036432.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update to sections 4.4 and 4.8 to include autoimmune hepatitis.

 

Section 4.4

Immune Reconstitution Inflammatory Syndrome

 

-----------------

Autoimmune disorders (such as Graves’ disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reconstitution; however, the reported time to onset is more variable and can occur many months after initiation of treatment.

 ---------------------

Section 4.8

Description of selected adverse reactions

 ------------
 

Metabolic parameters

Weight and levels of blood lipids and glucose may increase during antiretroviral therapy (see section 4.4).

In HIV-infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.  Autoimmune disorders (such as Graves’ disease and autoimmune hepatitis) have also been reported; however, the reported time to onset is more variable and can occur many months after initiation of treatment (see section 4.4).

---------------------

Updated on 26 September 2018

File name

PL_Norvir-100mg-PwdOralSusp_WS1411_13Sep18_1537961191.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 26 September 2018

File name

SPC_Norvir-100mg-PwdOralSusp_WS1411_13Sep18_1537961313.pdf

Reasons for updating

  • 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

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

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

Information added regarding the following interactions:

  • Ibrutinib

    Serum concentrations of ibrutinib may be increased due to CYP3A inhibition by ritonavir, resulting in increased risk for toxicity including risk of tumor lysis syndrome.  Co‑administration of ibrutinib and ritonavir should be avoided.  If the benefit is considered to outweigh the risk and ritonavir must be used, reduce the ibrutinib dose to 140 mg and monitor patient closely for toxicity.

     
  • Levothyroxine

    Post‑marketing cases have been reported indicating a potential interaction between ritonavir containing products and levothyroxine.
    Thyroid‑stimulating hormone (TSH) should be monitored in patients treated with levothyroxine at least the first month after starting and/or ending lopinavir/ritonavir treatment

     

Section 10 Date of Revision of the Text

Updated to 13 September 2018

Updated on 15 August 2018

File name

SPC_Norvir100mgpwdoralsuspMAH transfer_24May18_1534328582.pdf

Reasons for updating

  • File format updated to PDF

Legal category:Product subject to medical prescription which may not be renewed (A)

File name

PL_Norvir 100mg pwd oral susp_MAH transfer_24May18.pdf

Updated on 06 June 2018

File name

SPC_Norvir100mgpwdoralsuspMAH transfer_24May18.docx

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 06 June 2018

File name

PL_Norvir 100mg pwd oral susp_MAH transfer_24May18.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 06 September 2017

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 6 - date of revision

Updated on 06 September 2017

File name

PIL_16797_45.pdf

Reasons for updating

  • New PIL for new product

Updated on 05 September 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 05 September 2017

Reasons for 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

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.3 - Contraindications
        Addition of DDI with venetoclax to SmPC.
        The package Leaflet is updated accordingly.

Section 4.5 - Interaction with other medicinal products and other forms of interaction
        Addition of  DDI with venetoclax to SmPC.
        The package Leaflet is updated accordingly

Section 10 – Date of Revision of Text
        Updated to 08/2017

Updated on 20 July 2017

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

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 June 2017

Reasons for 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

Legal category:Product subject to medical prescription which may not be renewed (A)

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 12 June 2017

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 27 September 2016

Reasons for 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

Legal category:Product subject to medical prescription which may not be renewed (A)

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 27 September 2016

Reasons for updating

  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision

Updated on 14 July 2016

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 13 July 2016

Reasons for updating

  • New PIL for new product