AMGEVITA prefilled syringe
*Company:
Amgen Ireland LtdStatus:
UpdatedLegal 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
Updated on 24 October 2024
File name
ie_xi_amgevita_50mgmlapproved_spc_v38.pdf
Reasons for updating
- 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
Addition of the word "spontaneously" under “Malignancies and lymphoproliferative disorders” part of the section 4.8 of the SmPC
Updated on 03 June 2024
File name
ie_xi_amgevita_50mgml_approved_pfs pil_v36.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to section 7 - Instructions for use
Updated on 30 May 2024
File name
ie_xi_amgevita_50mgml_approved_pfs pil_v36.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to section 7 - Instructions for use
Updated on 30 May 2024
File name
ie_xi_amgevita_50mgml_approved_spc_v36.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 6.3 - Shelf life
- Change to section 6.5 - Nature and contents of container
- 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
SPC
4.2 Posology and method of administration
Editorial changes to Table headings:
Table 1. AMGEVITA dose for patients with pPolyarticular Jjuvenile Iidiopathic Aarthritis
Table 2. AMGEVITA dose for patients with eEnthesitis-rRelated aArthritis
Table 3. AMGEVITA dose for paediatric patients with pPlaque pPsoriasis
Table 5. AMGEVITA dose for paediatric patients with uUlcerative cColitis
Table 6. AMGEVITA dose for paediatric patients with uUveitis
6.3 Shelf life
32 years
6.5 Nature and contents of container
AMGEVITA 20 mg solution for injection in pre-filled syringe
0.4 mL solution in pre-filled syringe (type I glass) with a plunger stopper (bromobutyl rubber) and a stainless- steel needle with a needle shield (thermoplastic elastomer).
Pack size of 1one pre-filled syringe.
AMGEVITA 40 mg solution for injection in pre-filled syringe
0.8 mL solution in pre-filled syringe (type I glass) with a plunger stopper (bromobutyl rubber) and a stainless- steel needle with a needle shield (thermoplastic elastomer).
Pack sizes of 1one, two2, four4 or multipack of six6 (3 packs of x2) pre-filled syringes.
Not all pack sizes may be marketed.
AMGEVITA 40 mg solution for injection in pre-filled pen
0.8 mL solution for injection in pre-filled pen for patient use containing a pre-filled syringe (type I glass). The pen is a single use, disposable, handheld, mechanical injection device. The needle cover of the pre-filled pen is made from synthetic rubber.
Pack sizes of 1one, two2, four4 or multipack of six6 (3packs of x2) pre-filled pens.
Not all pack sizes may be marketed.
10. DATE OF REVISION OF THE TEXT
May 2024
Updated on 30 November 2023
File name
en_amgevita_approved_spc_v33_ie.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.5 - Nature and contents of container
- 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
latex warning for AMGEVITA 40 mg solution for injection in pre-filled pen
Updated on 30 November 2023
File name
en_amgevita_approved_spc_v33_ie.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.5 - Nature and contents of container
- 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
latex warning for AMGEVITA 40 mg solution for injection in pre-filled pen
Updated on 03 February 2023
File name
en_amgevita_approved_spc_r29 (1).pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 26 January 2022
File name
Ireland Patient Reminder Child TH4064 v2.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Key changes are as follows:
Removal of the Black Triangle and update of the Adverse Event Reporting statement to reflect the removal of the black triangle.
Information included in the patients cards to align with the information already in the Summary of Product Characteristics and Package Leaflet for patients that reside in regions where there are fungal infections.
Information included in the patient cards to align with the information already in the Summary of Product Chacteristics and Package Leaflet on the risk of getting infections and cancer risk.
Updated on 26 January 2022
File name
Ireland Patient Reminder Adult TH4064 v2.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Key changes are as follows:
Removal of the Black Triangle and update of the Adverse Event Reporting statement to reflect the removal of the black triangle.
Information included in the patients cards to align with the information already in the Summary of Product Characteristics and Package Leaflet for patients that reside in regions where there are fungal infections.
Information included in the patient cards to align with the information already in the Summary of Product Chacteristics and Package Leaflet on the risk of getting infections and cancer risk.
Updated on 15 December 2021
File name
en_amgevita_approved_pil_pfs_r29.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - use in children and adolescents
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Removal of Black Inverted Triangle
Free text change information supplied by the pharmaceutical company
Section | New/revised text in blue & bold and deleted text in strkethrough |
Introduction
|
Removal of the black triangle |
What AMGEVITA is and what it is used for |
….. AMGEVITA contains the active substance adalimumab, a medicine that acts on your body’s immune (defence) system. ……
|
What AMGEVITA is and what it is used for |
…… Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis are inflammatory diseases of the joints that usually first appear in childhood. …….
|
2. What you need to know before you use AMGEVITA Do not use AMGEVITA:
|
….. Vaccinations if you have a severe infection, including active tuberculosis, sepsis (blood infection) or other opportunistic infections (unusual infections associated with a weakened immune system) (see “Warnings and precautions”). It is important that you tell your doctor if you have symptoms of infections, e.g. fever, wounds, feeling tired, dental problems. ……
|
2. What you need to know before you use AMGEVITA Warnings and precautions
|
…… Certain vaccines contain living but weakened forms of disease-causing bacteria or viruses that may cause infections and should not be given while receiving AMGEVITA. …….. |
2. What you need to know before you use AMGEVITA Children and adolescents
|
….. Children and adolescents
…….
|
3. How to use AMGEVITA
|
…… Method and route of administration AMGEVITA is administered by injection under the skin (subcutaneous injection). Detailed instructions on how to inject AMGEVITA are provided in “Instructions for use” section. ……..
|
4. Possible side effects
|
…….. Tell your doctor immediately if you notice any of the following signs of allergic reaction or heart failure:
Tell your doctor as soon as possible if you notice any of the following: ……..
……
Common (may affect up to 1 in 10 people ……
…..
Uncommon (may affect up to 1 in 100 people) ….
….
Rare (may affect up to 1 in 1,000 people) ……
….
….
|
Updated on 15 December 2021
File name
en_amgevita_approved_spc_r29.pdf
Reasons for updating
- Change to section 10 - Date of revision of the text
- Improved presentation of SPC
- Removal of Black Inverted Triangle
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section
|
Details of changes (new text in blue/bold and delete text in strikethrough) |
Introduction |
Removal of the black triangle
|
Throughout the Summary Product Characteristics |
Formatting/typographical corrections Formatting improvements |
10. DATE OF REVISION OF THE TEXT
|
December 2021 |
Updated on 05 August 2021
File name
en_amgevita_approved_pil PFS_v21.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 3 - dose and frequency
- Change to section 3 - use in children/adolescents
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 05 August 2021
File name
en_amgevita_approved_spc_v27.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- 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)
Free text change information supplied by the pharmaceutical company
Originator alignment:
Addition of indication for paediatric Ulcerative Colitis section 4.1; associated updates to sections 4.2 and 5.1 and 5.2
Addition of Kaposi sarcoma and Weight increased (unknown frequency) section 4.8
Updated on 27 February 2020
File name
en_amgevita_approved_spc_v21.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic 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 5.1: Additional text and updated information regarding uncontrolled open-label extension study in uveitis patients
Updated on 18 June 2019
File name
ED69837 Amgevita CHILD PAC - PROOF.pdf
Reasons for updating
- Replace File
Updated on 18 June 2019
File name
ED69837 Amgevita ADULT PAC - PROOF.pdf
Reasons for updating
- Replace File
Updated on 18 June 2019
File name
en_amgevita_approved_pil PFS_v_pfs latex removal.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Updated on 18 June 2019
File name
en_amgevita_approved_spc_v_pfs latex removal.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.5 - Nature and contents of container
- 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 4.4 Warnings and Precautions |
Dry natural rubber The needle cover of the pre-filled |
Section 6.5 Nature and contents of container |
AMGEVITA 20 mg solution for injection in pre-filled syringe 0.4 mL solution in pre-filled syringe (type I glass) with a plunger stopper (bromobutyl rubber) and a stainless steel needle with a needle shield (thermoplastic elastomer). Pack size of one pre-filled syringe.
AMGEVITA 40 mg solution for injection in pre-filled syringe 0.8 mL solution in pre-filled syringe (type I glass) with a plunger stopper (bromobutyl rubber) and a stainless steel needle with a needle shield (thermoplastic elastomer). Pack sizes of one, two, four or multipack of six (3x2) pre-filled syringes. Not all pack sizes may be marketed. |
Section 10 Date of revision of the text |
June 2019 |
Updated on 19 March 2019
File name
en_amgevita_approved_pil_v15_PFS.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 3 - dose and frequency
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 18 March 2019
File name
en_amgevita_approved_spc_v15.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- 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 5.1 - 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)
Free text change information supplied by the pharmaceutical company
Section 4.1 Therapeutic indications |
Hidradenitis suppurativa (HS) AMGEVITA is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy (see sections 5.1 and 5.2).
Paediatric uveitis AMGEVITA is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate. |
||||||||||||||||||
Section 4.2 Posology |
“Special alert card” is now called the “Patient Reminder Card” Adolescent hidradenitis suppurativa (from 12 years of age, weighing at least 30 kg) There are no clinical trials with adalimumab in adolescent patients with HS. The posology of AMGEVITA in these patients has been determined from pharmacokinetic modelling and simulation (see section 5.2). The recommended AMGEVITA dose is 80 mg at Week 0 followed by 40 mg every other week starting at Week 1 via subcutaneous injection. In adolescent patients with inadequate response to AMGEVITA 40 mg every other week, an increase in dosage to 40 mg every week or 80 mg every other week may be considered. Antibiotics may be continued during treatment with AMGEVITA if necessary. It is recommended that the patient should use a topical antiseptic wash on their HS lesions on a daily basis during treatment with AMGEVITA. Continued therapy beyond 12 weeks should be carefully reconsidered in a patient with no improvement within this time period. Should treatment be interrupted, AMGEVITA may be re-introduced as appropriate. The benefit and risk of continued long-term treatment should be periodically evaluated (see adult data in section 5.1). There is no relevant use of AMGEVITA in children aged less than 12 years in this indication.
Paediatric uveitis The recommended dose of AMGEVITA for paediatric patients with uveitis from 2 years of age is based on body weight (table 5). AMGEVITA is administered via subcutaneous injection. In paediatric uveitis, there is no experience in the treatment with AMGEVITA without concomitant treatment with methotrexate.
When AMGEVITA therapy is initiated, a loading dose of 40 mg for patients < 30 kg or 80 mg for patients ≥ 30 kg may be administered one week prior to the start of maintenance therapy. No clinical data are available on the use of a AMGEVITA loading dose in children < 6 years of age (see section 5.2). There is no relevant use of AMGEVITA in children aged less than 2 years in this indication. It is recommended that the benefit and risk of continued long-term treatment should be evaluated on a yearly basis (see section 5.1). |
||||||||||||||||||
Section 4.4 Warnings and Precautions |
BCG provided as an example of a live vaccine: Vaccinations Patients on AMGEVITA may receive concurrent vaccinations, except for live vaccines. Administration of live vaccines (e.g., BCG vaccine) to infants exposed to AMGEVITA in utero is not recommended for 5 months following the mother’s last AMGEVITA injection during pregnancy. |
||||||||||||||||||
Section 4.6 Fertility, pregnancy and lactation |
Women of child bearing potential Women of childbearing potential should consider the use of adequate contraception to prevent pregnancy and continue its use for at least five months after the last AMGEVITA treatment. Pregnancy A large number (approximately 2100) of prospectively collected pregnancies exposed to adalimumab resulting in live birth with known outcomes, including more than 1500 exposed during the first trimester, does not indicate an increase in the rate of malformation in the newborn. In a prospective cohort registry, 257 women with rheumatoid arthritis (RA) or Crohn’s disease (CD) treated with adalimumab at least during the first trimester and 120 women with RA or CD not treated with adalimumab were enrolled. The primary endpoint was the birth prevalence of major birth defects. The rate of pregnancies ending with at least one live born infant with a major birth defect was 6/69 (8.7%) in the adalimumab-treated women with RA and 5/74 (6.8%) in the untreated women with RA (unadjusted OR 1.31, 95% CI 0.38-4.52) and 16/152 (10.5%) in the adalimumab-treated women with CD and 3/32 (9.4%) in the untreated women with CD (unadjusted OR 1.14, 95% CI 0.31-4.16). The adjusted OR (accounting for baseline differences) was 1.10 (95% CI 0.45-2.73) with RA and CD combined. There were no distinct differences between adalimumab-treated and untreated women for the secondary endpoints spontaneous abortions, minor birth defects, preterm delivery, birth size and serious or opportunistic infections and no stillbirths or malignancies were reported. The interpretation of data may be impacted due to methodological limitations of the study, including small sample size and non-randomised design. In a developmental toxicity study conducted in monkeys, there was no indication of maternal toxicity, embryotoxicity or teratogenicity. Preclinical data on postnatal toxicity of adalimumab are not available (see section 5.3). Due to its inhibition of TNFα, adalimumab administered during pregnancy could affect normal immune responses in the new born. AMGEVITA should only be used during pregnancy if clearly needed. Adalimumab may cross the placenta into the serum of infants born to women treated with adalimumab during pregnancy. Consequently, these infants may be at increased risk for infection. Administration of live vaccines (e.g., BCG vaccine) to infants exposed to adalimumab in utero is not recommended for 5 months following the mother’s last adalimumab injection during pregnancy. Breast-feeding Limited information from the published literature indicates that adalimumab is excreted in breast milk at very low concentrations with the presence of adalimumab in human milk at concentrations of 0.1% to 1% of the maternal serum level. Given orally, immunoglobulin G proteins undergo intestinal proteolysis and have poor bioavailability. No effects on the breastfed newborns/infants are anticipated. Consequently, AMGEVITA can be used during breastfeeding. Fertility Preclinical data on fertility effects of adalimumab are not available. |
||||||||||||||||||
4.8 Undesirable effects |
Lichenoid skin reaction added as a rare adverse reaction |
||||||||||||||||||
5.1 Pharmacodynamic properties |
New subsections for adolescent HS and paediatric uveitis |
||||||||||||||||||
5.2 Pharmacokinetic properties |
New subsections for adolescent HS and paediatric uveitis |
||||||||||||||||||
Section 10 Date of revision of the text |
March 2019 |
Updated on 23 November 2018
File name
UKIE-NPC-AMG-0818-067141b Amgevita PAC paed IE.pdf
Reasons for updating
- Add New Doc
Updated on 23 November 2018
File name
UKIE-NPC-AMG-0818-067141a Amgevita PAC adult IE.pdf
Reasons for updating
- Add New Doc
Updated on 05 November 2018
File name
en_amgevita_approved_pil PFS_v12.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 05 November 2018
File name
en_amgevita_approved_spc_v12.pdf
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 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)
Free text change information supplied by the pharmaceutical company
Section 4.2 Posology |
Rheumatoid arthirtis – addition of option for dosing every other week for patients who require an increase in dosage Psoriasis - addition of option for dosing every other week for patients who require an increase in dosage Hidradenitis suppurativa – addition of option for dosing every other week Crohn’s disease - addition of option for dosing every other week for patients who require an increase in dosage Ulcerative colitis - addition of option for dosing every other week for patients who require an increase in dosage
Polyarticular juvenile idiopathic arthritis from 2 years of age – addition of weight-based fixed dosing Enthesitis-related arthritis – addition of weight-based fixed dosing Paediatric plaque psoriasis - addition of weight-based fixed dosing Paediatric Crohn’s disease – addition of weight-based fixed dosing |
Section 4.4 Warnings and Precautions |
Addition of excipients information:
Excipients with known effects This medicinal product contains less than 1 mmol of sodium (23 mg) per 0.8 ml dose, i.e. essentially ‘sodium-free’. |
Section 5 Pharmacological Properties |
Addition of information on non-radiographic axial spondyloarthritis following final results from originator remission-withdrawal-retreatment study (M13-375).
|
Section 10 Date of revision of the text |
October 2018 |
Updated on 15 October 2018
File name
en_amgevita_approved_pil_June 2018 PFS.pdf
Reasons for updating
- New PIL for new product
Updated on 15 October 2018
File name
en_amgevita_approved_spc_v009_v011.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)