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Symtuza 800 mg/150 mg/200 mg/10 mg film coated tablets

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 01/02/21

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Summary of Product Characteristics last updated on medicines.ie: 1/2/2021
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

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Janssen Sciences Ireland

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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 1 February 2021 PIL

Reasons for updating

  • Change to section 5 - how to store or dispose

Updated on 1 February 2021 SPC

Reasons for updating

  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text

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

Updated on 15 October 2020 SPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • 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 15 October 2020 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 3 - use in children/adolescents

Updated on 8 July 2019 PIL

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 6 July 2019 SPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • 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)

Updated on 5 July 2019 SPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • 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)

Updated on 9 May 2019 PIL

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 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 8 May 2019 SPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • 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)

Updated on 27 November 2018 PIL

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 November 2018 SPC

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

4.3     Contraindications

 

  • Added    dabigatran,
     
    4.5     Interaction with other medicinal products and other forms of interaction
     

ANTICOAGULANT/PLATELET AGGREGATION INHIBITOR

Apixaban

Edoxaban

Dabigatran etexilate

Rivaroxaban

Based on theoretical considerations co‑administration of DRV/COBI with these anticoagulants may increase concentrations of the anticoagulant, which may lead to an increased bleeding risk.

(CYP3A and/or P‑glycoprotein inhibition)

Co‑administration of Symtuza and these anticoagulants is not recommended.

Dabigatran

Ticagrelor

Based on theoretical considerations co‑administration of DRV/COBI with dabigatran or ticagrelor may increase concentrations of the anticoagulant.

(CYP3A and/or P‑glycoprotein inhibition).

Concomitant administration of Symtuza with dabigatran or ticagrelor is contraindicated (see section 4.3).

 

Use of other antiplatelets not affected by CYP inhibition or induction (e.g. prasugrel) is recommended.

 

 

Glecaprevir/pibrentasvir

Based on theoretical considerations DRV/COBI may increase the exposure to glecaprevir and pibrentasvir.

(P‑gp, BCRP and/or OATP1B1/3 inhibition)

It is not recommended to co‑administer Symtuza with glecaprevir/pibrentasvir.

Updated on 30 October 2018 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Change in co-marketing arrangement

Updated on 29 October 2018 SPC

Reasons for updating

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

4.4     Special warnings and precautions for use 

Immune reactivation syndrome 

 

Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment (see section 4.8).

 

4.8     Undesirable effects 

Immune reconstitution inflammatory syndrome

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 these events can occur many months after initiation of treatment (see section 4.4).

Updated on 29 October 2018 SPC

Reasons for updating

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

 

Immune reactivation syndrome

 

Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment (see section 4.8).

 

Updated on 26 September 2018 SPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • 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 6.3

Shelf life increased for 2 to 3 years

Updated on 11 July 2018 SPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.2 - Pharmacokinetic properties

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

Free text change information supplied by the pharmaceutical company

Section 4.2 – Addition of pregnancy and postpartum section to inform about low darunavir exposure and consideration for alternative regimen.

Section 4.4 – Addition of pregnancy data (low darunavir exposure, cobicistat levels decrease and may not provide sufficient boosting); advice not to initiate during pregnancy or switch to alternative regimen.

Section 4.6 -  addition of pregnancy data: low darunavir exposure which may be associated with an increased risk of treatment failure and an increased risk of HIV transmission to the child; advice not to initiate during pregnancy or switch to alternative regimen.

Section 5.2 – addition of pregnancy and postpartum data.

Updated on 11 July 2018 PIL

Reasons for updating

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

Updated on 29 May 2018 SPC

Reasons for updating

  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

 · Administrative changes to sections 4.1, 4.2, 4.4, 4.5, 4.7, 4.8, 5.1.

​​· Section 4.7 deletion of “no or negligible influence on the ability to drive and use machines” statement.

​​· Section 4.8 Changes to frequency of adverse reactions; addition of increased low density lipoprotein (common); dyslipidaemia and hyperglycemia (both uncommon)

​​· Section 5.1 addition of ATC code; addition of AMBER and EMERALD trial data

Updated on 29 May 2018 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 26 March 2018 SPC

Reasons for updating

  • New SPC for new product

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

Updated on 26 March 2018 SPC

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 4.9 - Overdose
  • 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

4.3     Contraindications

 

-                 , simvastatin, and lovastatin and lomitapide  (see section 4.5)

 

 

4.5     Interaction with other medicinal products and other forms of interaction

 

 

Co‑administration of Symtuza and other medicinal products that inhibit CYP3A may decrease the clearance of darunavir and cobicistat and may result in increased plasma concentrations of darunavir and cobicistat (e.g. systemic azole antifungals like ketoconazole and clotrimazole). These interactions are described in the interaction table below.

 

 

Clonazepam

Based on theoretical considerations Symtuza is expected to  increase concentrations of clonazepam

(inhibition of CYP3A)

Clinical monitoring is recommended when co‑administering Symtuza with clonazepam.

 

 

ANTIPSYCHOTICS/NEUROLEPTICS

Perphenazine

Risperidone

Thioridazine

 

 

 

 

 

 

 

Lurasidone

Pimozide

Quetiapine

Sertindole

Based on theoretical considerations DRV/COBI is expected to increase these neuroleptic plasma concentrations.

(CYP3A, CYP2D6 and/or P‑gp inhibition inhibition)

 

 

Clinical monitoring is recommended when co‑administering Symtuza with perphenazine, risperidone or thioridazine. For these neuroleptics, consider reducing the dose of the neuroleptic upon co‑administration with Symtuza.

 

The combination of lurasidone, pimozide, quetiapine or sertindole and Symtuza is contraindicated (see section 4.3).

 

 

HMG CO‑A REDUCTASE INHIBITORS

Atorvastatin

Fluvastatin

Pitavastatin

Pravastatin

Rosuvastatin

 

 

 

 

 

 

 

 

 

 

Lovastatin

Simvastatin

Atorvastatin (10 mg once daily):

atorvastatin AUC ↑ 290%

atorvastatin Cmax ↑ 319%

atorvastatin Cmin ND

 

Rosuvastatin (10 mg once daily):

rosuvastatin AUC ↑ 93%

rosuvastatin Cmax ↑ 277%

rosuvastatin Cmin ND

 

Based on theoretical considerations DRV/COBI is expected to increase these HMG Co‑A reductase inhibitor plasma concentrations of fluvastatin, pitavastatin, pravastatin, lovastatin and simvastatin.

(CYP3A inhibition and/or transport)

Concomitant use of a HMG CoA reductase inhibitor and Symtuza may increase plasma concentrations of the lipid lowering agent, which may lead to adverse reactions such as myopathy.

When administration of HMG CoA reductase inhibitors and Symtuza is desired, it is recommended to start with the lowest dose and titrate up to the desired clinical effect while monitoring for safety.

 

Concomitant use of Symtuza with lovastatin and simvastatin is contraindicated (see section 4.3).

OTHER LIPID MODIFYING AGENTS

Lomitapide

Based on theoretical considerations, Symtuza is expected to increase the exposure of lomitapide when co-administered.

(CYP3A inhibition)

Co-administration is contraindicated (see section 4.3)

 

 

OESTROGEN‑BASED CONTRACEPTIVES

Drospirenone Ethinylestradiol (3 mg/0.02 mg once daily)

 

 

Ethinyl estradiol

 

 

 

 

Norethindrone

drospirenone AUC ↑ 58%

drospirenone Cmax ↑ 15%

drospirenone Cmin ND

 

ethinylestradiol AUC ¯ 30%

ethinylestradiol Cmax ¯ 14%

ethinylestradiol Cmin ND

 

 

Based on theoretical considerations DRV/COBI may alter ethinyl estradiol and/or norethindrone plasma concentrations.

 

Alternative or additional contraceptive measures are recommended when oestrogen based contraceptives are co administered with Symtuza. Patients using oestrogens as

 hormone replacement therapy

 should be clinically monitored for signs of oestrogen deficiency.

When Symtuza is coadministered with a drospirenone-containing product, clinical monitoring is recommended due to the potential for hyperkalaemia.

 

No dosing recommendations can be made on the use of Symtuza with oral contraceptives. Alternative forms of contraception should be considered.

 

4.9     Overdose

Treatment of overdose with Symtuza consists of general supportive measures, including monitoring of vital signs as well as observation of the clinical status of the patient. If indicated, elimination of unabsorbed active substance is to be achieved by emesis.

Updated on 23 March 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 23 March 2018 PIL

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 6 November 2017 SPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - Marketing authorisation number(s)
  • 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



6.5     Nature and contents of container

 

White, high density polyethylene (HDPE) bottle with a silica gel desiccant (contained in a separate sachet or canister) fitted with polypropylene (PP) child resistant closure with induction seal.

 

Pack size of oneEach bottle containsing 30 tablets.

Pack size of one bottle or three bottles per carton.

Not all pack sizes may be marketed




8.       MARKETING AUTHORISATION NUMBER(S)

 

EU/1/17/1225/001- 30 film-coated tablets

EU/1/17/1225/002- 90 film-coated tablets (3 x 30)

Updated on 6 November 2017 PIL

Reasons for updating

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

Updated on 2 October 2017 SPC

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 2 October 2017 PIL

Reasons for updating

  • New PIL for new product