Drugs List

Therapeutic Indications

Uses

Emphysema associated with alpha-1-antitrypsin deficiency

Maintenance treatment to slow the progression of emphysema in adults with documented severe alpha 1-proteinase inhibitor deficiency, despite optimal treatment with other standard therapies.

Contraindications

Children under 18 years
Breastfeeding
Immunoglobulin A deficiency with IgA antibodies

Precautions and Warnings

Patients over 65 years
Restricted sodium intake
Pregnancy

Contains more than 1 mmol (23 mg) sodium per dose
Advise ability to drive/operate machinery may be affected by side effects
Treatment to be initiated and supervised by a specialist
Derived from human plasma. Transmission of infective agents possible.
Do not mix with other drugs or substances
For single use only
Must be given as an intravenous infusion
Record name and batch number of administered product
Vaccinate patients receiving this product against hepatitis A and B
Monitor vital signs during initial stage of infusion
Advise patient to report symptoms of allergic type hypersensitivity
Consider discontinuing if suspected allergic reaction occurs
Interrupt therapy/reduce infusion rate if infusion-related reactions occur
Management of cases of shock should follow current medical standards
Advise patient on giving up smoking

Infusion rate

During the first infusions, patient's clinical state, including vital signs, should be closely monitored throughout the infusion period. If any reaction takes place that might be related to the administration of human alpha 1-proteinase inhibitor, the rate of infusion should be decreased or the administration should be stopped, as required by the clinical condition of the patient. If symptoms subside promptly after stopping, the infusion may be resumed at a lower rate that is comfortable for the patient.

Transmissible agents

Standard safety measures to prevent infections resulting from the use of medicinal agents prepared from human blood or plasma include rigorous selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation and removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens.

Pregnancy and Lactation

Pregnancy

Use alpha1-proteinase inhibitor human with caution during pregnancy.

The manufacturer advises caution if alpha 1-proteinase inhibitor is used during pregnancy. Although there have been no studies in animal reproduction, as alpha1-proteinase inhibitor is an endogenous human protein, when given at the recommended dose it is unlikely to cause harm to the foetus.

Lactation

Alpha1-proteinase inhibitor human is contraindicated in breastfeeding.

It is not known if alpha1-proteinase inhibitor human is excreted in human milk. The excretion of this agent has not been studied in animals. The manufacturer notes that a decision must be made whether to discontinue breastfeeding or to discontinue the therapy, taking into account the benefit of breastfeeding for the child and the benefit of the therapy for the woman.

Side Effects

Anaphylactic reaction
Asthenia
Chest pain
Chills
Confusion
Dizziness
Dyspnoea
Eye swelling
Facial swelling
Flushing
Headache
Hyperhidrosis
Hypersensitivity reactions
Hypoaesthesia
Hypotension
Hypoxaemia
Injection site reactions
Lip enlargement
Lymph node pain
Nausea
Paraesthesia
Pharyngeal oedema
Pruritus
Pyrexia
Rash
Syncope
Tachycardia
Urticaria

Presentation

Infusions of alpha1-proteinase inhibitor human.

Drugs List

Therapeutic Indications

Uses

Emphysema associated with alpha-1-antitrypsin deficiency

Maintenance treatment to slow the progression of emphysema in adults with documented severe alpha 1-proteinase inhibitor deficiency, despite optimal treatment with other standard therapies.

Dosage

Adults

Contraindications

Children under 18 years
Breastfeeding
Immunoglobulin A deficiency with IgA antibodies

Precautions and Warnings

Patients over 65 years
Restricted sodium intake
Pregnancy

Contains more than 1 mmol (23 mg) sodium per dose
Advise ability to drive/operate machinery may be affected by side effects
Treatment to be initiated and supervised by a specialist
Derived from human plasma. Transmission of infective agents possible.
Do not mix with other drugs or substances
For single use only
Must be given as an intravenous infusion
Record name and batch number of administered product
Vaccinate patients receiving this product against hepatitis A and B
Monitor vital signs during initial stage of infusion
Advise patient to report symptoms of allergic type hypersensitivity
Consider discontinuing if suspected allergic reaction occurs
Interrupt therapy/reduce infusion rate if infusion-related reactions occur
Management of cases of shock should follow current medical standards
Advise patient on giving up smoking

Infusion rate

During the first infusions, patient's clinical state, including vital signs, should be closely monitored throughout the infusion period. If any reaction takes place that might be related to the administration of human alpha 1-proteinase inhibitor, the rate of infusion should be decreased or the administration should be stopped, as required by the clinical condition of the patient. If symptoms subside promptly after stopping, the infusion may be resumed at a lower rate that is comfortable for the patient.

Transmissible agents

Standard safety measures to prevent infections resulting from the use of medicinal agents prepared from human blood or plasma include rigorous selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation and removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens.

Pregnancy and Lactation

Pregnancy

Use alpha1-proteinase inhibitor human with caution during pregnancy.

The manufacturer advises caution if alpha 1-proteinase inhibitor is used during pregnancy. Although there have been no studies in animal reproduction, as alpha1-proteinase inhibitor is an endogenous human protein, when given at the recommended dose it is unlikely to cause harm to the foetus.

Lactation

Alpha1-proteinase inhibitor human is contraindicated in breastfeeding.

It is not known if alpha1-proteinase inhibitor human is excreted in human milk. The excretion of this agent has not been studied in animals. The manufacturer notes that a decision must be made whether to discontinue breastfeeding or to discontinue the therapy, taking into account the benefit of breastfeeding for the child and the benefit of the therapy for the woman.

Side Effects

Anaphylactic reaction
Asthenia
Chest pain
Chills
Confusion
Dizziness
Dyspnoea
Eye swelling
Facial swelling
Flushing
Headache
Hyperhidrosis
Hypersensitivity reactions
Hypoaesthesia
Hypotension
Hypoxaemia
Injection site reactions
Lip enlargement
Lymph node pain
Nausea
Paraesthesia
Pharyngeal oedema
Pruritus
Pyrexia
Rash
Syncope
Tachycardia
Urticaria

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: March 2020.

Reference Sources

Summary of Product Characteristics: Respreeza 1,000 mg powder and solvent for solution for infusion. CSL Behring UK Limited. October 2018.