HyQvia 100 mg/ml solution for infusion for subcutaneous use

Amendment to Section 1, 2, 3, 4, 5, 6

Amendment to the following sections:

2.        QUALITATIVE AND QUANTITATIVE COMPOSITION

3.        PHARMACEUTICAL FORM

4.1    Therapeutic indications

4.2    Posology and method of administration

4.3    Contraindications

4.4    Special warnings and precautions for use

4.5    Interaction with other medicinal products and other forms of interaction

4.6    Fertility, pregnancy and lactation

4.7    Effects on ability to drive and use machines

4.8    Undesirable effects

4.9    Overdose

5.1    Pharmacodynamic properties

5.2    Pharmacokinetic properties

5.3    Preclinical safety data

6.3    Shelf life

6.4    Special precautions for storage

6.5    Nature and contents of container

6.6    Special precautions for disposal and other handling

10.    DATE OF REVISION OF THE TEXT

Update to section 4.6 of the SmPC to update the safety information concerning fertility, pregnancy and lactation

The updates are to the administration instructions in the Patient Leaflet:

Step 3

Cap: Purple protective Protective cap is on the dual vial unit. Do not use the product if it does not have the cap.

Step 5 

Remove purple protective cap(s) and make sure the blue vial caps are removed. If not, manually remove the blue caps to expose the vial stoppers.

• Section 1. What HyQvia is and what it is used for.

Removal and addition of the following text: 

• patients with a certain kind of blood cancer (chronic lymphocytic leukaemia) which leads to a lack of antibody production and recurrent infections when preventative antibiotics have failed.
• patients with a specific cancer of the bone marrow (multiple myeloma) and lack of antibody production with recurrent infections who have failed to respond to a vaccine against certain bacteria (pneumococci).
• patients with low antibody production prior and after transplantation of bone marrow cells from another person.
• patients who experience severe or recurrent infections due to a weakened immune system resulting from other conditions or treatments

•  2.           What you need to know before you use HyQvia

  HyQvia contains sodium 

  Addition of the following text:

  This medicine contains 5.0 – 60.5 mg sodium (main component of cooking/table salt) in each recombinant human hyaluronidase vial of HyQvia. This is equivalent to 0.25 – 3% of the recommended maximum daily dietary intake of sodium for an adult. The IG 10% component is essentially sodium-free.

• 4.       Possible side effects

Removal of the duplicated text:

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

• Revision date: 03 September 2020
•  

• Minor Administrative Changes to Sections 1, 2, 4.6, 5.1, 5.2, 6.5
• Section 3 PHARMACEUTICAL FORM: 

  IG 10% is a clear or slightly opalescent and colourless or pale yellow solution. The solution has a of pH 4.6-5.1 and an osmolality of 240 – 300 mOsmol/kg.

  Recombinant human hyaluronidase is a clear, colourless solution. The solution has a pH of 6.5-8.0 and an osmolality of 290 – 350 mOsmol/kg.

• 4.1 Therapeutic indications. Extension of indication: “Secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF)* or serum IgG level of <4 g/l. (*PSAF = failure to mount at least a 2-fold rise in IgG antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccines). Removal of: 

Hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia (CLL), in whom prophylactic antibiotics have failed or are contra‑indicated.

Hypogammaglobulinaemia and recurrent bacterial infections in multiple myeloma (MM) patients.

Hypogammaglobulinaemia in patients pre‑ and post‑allogeneic hematopoietic stem cell transplantation (HSCT).

• 4.2     Posology and method of administration

  In replacement therapy the dose may need to be individualized for each patient dependent on the pharmacokinetic and clinical response. Dose based on bodyweight may require adjustment in underweight or overweight patients.

  The following dosage regimens are given as a guideline:

  Replacement therapy in primary immunodeficiency syndromes (as defined in 4.1)

  Secondary immunodeficiencies (as defined in 4.1.)

  The recommended dose is 0.2-0.4 g/kg every three to four weeks.

  IgG trough levels should be measured and assessed in conjunction with the incidence of infection. Dose should be adjusted as necessary to achieve optimal protection against infections, an increase may be necessary in patients with persisting infection; a dose decrease can be considered when the patient remains infection free.

• 4.4     Special warnings and precautions for use:

  Removal of: The IG 10% component contains trace amounts of sodium. Recombinant human hyaluronidase contains 4.03 mg sodium per ml, with a maximum daily dose of approximately 120 mg. This should be taken into consideration in patients on a controlled sodium diet.

         Sodium content- updated​​​​​​​

• 4.7     Effects on ability to drive and use machines:

Hyqvia has no or negligible influence on the ability to drive and use machines, e.g. dizziness (see section 4.8).

Previously: The ability to drive and operate machines may be impaired by some adverse reactions associated with HyQvia. Patients who experience adverse reactions during treatment should wait for these to resolve before driving or operating machines

• 4.8     Undesirable effects- removal of  frequencies from the table.

In section 4.2 (posology and method of administration), changes have been made in line with CCDS.

In section 4.8 (undesirable effects), a new subheading "Infections and infestations: Meningitis aseptic" has been added to the post table adverse reactions reported from post‑marketing experience.

In section 9 (date of first authorisation/renewal of the authorisation), the date of renewal "8 January 2018" has been added.

In section 10 (date of revision of the text), the new date of revision has been added.

• In section 4.2 (posology and method of administration), information about infusion site leakage has been included.
• In section 4.8 (undesirable effects), information about infusion site leakage has been included.

Section 4.1 – Inclusion of children and adolescents (0-18 years) in indications

Section 4.2 - Inclusion of information on paediatric population

Section 4.4 - Inclusion of information on paediatric population

Section 4.5 - Inclusion of information on paediatric population

Section 4.8 – Update to tabulated list of AEs and inclusion of information on paediatric population

Section 5.1 – Inclusion of information on extension clinical study and update to information on paediatric population

Section 2, Qualitative and quantitative composition:

Amendment to wording for vial contents to “human normal immunoglobulin” and amendment to quantification of total sodium content.

Section 4.1, Therapeutic indications:

Rewording of indications in line with EU core SmPC.

Section 4.2, Posology and method of administration:

Repositioning of tables and text, rewording of text on administration and inclusion of table on infusion rates.

4.3, Contraindications:

Addition of “must not be given intravenously”.

4.4, Special warnings and precautions for use:

Prominence given to “If HyQvia is accidentally administered into a blood vessel patients could develop shock.” Repositioning of text on potential complications, addition of sub-section “Immunogenicity of recombinant human hyaluronidase”, rewording of sub-sections

·         Hypersensitivity to IG 10%

·         Hypersensitivity to recombinant human hyaluronidase

·         Thromboembolism

·         Haemolytic anaemia

·         Acute renal failure

·         Aseptic meningitis syndrome

·         Interference with serological testing

·         Transmissible agents

4.5, Interactions; 4.6, Fertility, pregnancy and lactation:

Minor change

4.7, Effects on ability to drive and use machines:

Changes to effects.

4.9, Overdose:

Removal of text on intravenous use.

5.1, Pharmacodynamic properties:

Rewording of “Mechanism of action” sub-section.

5.2, Pharmacokinetic properties:

Minor rewording.

5.3, Preclinical safety data:

Changes to wording regarding non-clinical studies.

6.6. Special precautions:

Addition of “Do not use heating devices including microwaves” and rewording on visual inspection.