Glatiramer

L03A - Cytokines and immunomodulators ATC L03AX13

JFDA label: Glitaxon 20mg/ml

Indications

Approved

Multiple sclerosis

Contraindications

Source: Lexicomp

Hypersensitivity to glatiramer acetate, mannitol, or any component of the formulation Absolute

Adverse Reactions

Very Common >10%Common 1–10%Uncommon 0.1–1% Rare 0.01–0.1%Very Rare <0.01%Not Known

Cardiac disorders (9)

Very Common chest pain · Vasodilatation

Common edema · facial edema · hypertension · Palpitations · peripheral edema · syncope · tachycardia

Nervous system disorders (9)

Very Common anxiety · Pain

Common abnormal dreams · chills · emotional lability · Migraine · nervousness · speech disturbance · stupor

Renal and urinary disorders (6)

Common abnormal Pap smear · hematuria · impotence · Urinary urgency · vaginal hemorrhage · vulvovaginal candidiasis

Blood and lymphatic system disorders (3)

Common benign skin neoplasm · Bruise · lymphadenopathy

Immune system disorders (3)

Very Common Development of IgG antibodies · Immediate hypersensitivity

Common Hypersensitivity

Metabolism and nutrition disorders (3)

Common amenorrhea · hypermenorrhea · Weight gain

Gastrointestinal disorders (9)

Very Common Nausea

Common aphthous stomatitis · bowel urgency · dental caries · dysphagia · enlargement of salivary glands · gastroenteritis · oral candidiasis · Vomiting

Skin and subcutaneous tissue disorders (10)

Very Common diaphoresis · Skin rash

Common eczema · erythema · Hyperhidrosis · pruritus · pustular rash · skin atrophy · urticaria · warts

Musculoskeletal and connective tissue disorders (5)

Very Common back pain · Weakness

Common laryngospasm · Neck pain · tremor

Eye disorders (2)

Common Diplopia · visual field defect

Infections and infestations (3)

Very Common Infection

Common Abscess · herpes zoster

General disorders and administration site conditions (12)

Very Common erythema at injection site · Inflammation at injection site · itching at injection site · pain at injection site · residual mass at injection site · swelling

Common abscess at injection site · Bleeding at injection site · Fever · fibrosis at injection site · hypersensitivity reaction at injection site · lipoatrophy at injection site

Respiratory, thoracic and mediastinal disorders (9)

Very Common Dyspnea · flu-like symptoms · nasopharyngitis

Common bronchitis · cough · hyperventilation · laryngismus · Rhinitis · viral respiratory tract infection

Dosing

Source: Lexicomp

Multiple sclerosis (MS) (relapsing): SubQ: Note: Glatiramer 20 mg/mL and 40 mg/mL formulations are not interchangeable. MS (relapsing-remitting): 20 mg once daily or 40 mg 3 times per week administered at least 48 hours apart

Refer to adult dosing.

Warnings & Precautions

Source: Lexicomp

Chest pain

May or may not occur with the immediate postinjection reaction; described as a transient pain usually resolving in a few minutes; often unassociated with other symptoms. Episodes usually begin ≥1 month after initiation of treatment.

Hypersensitivity reactions

Anaphylactoid reactions (rare) have been reported.

Immune response

Although there has not been a systematic evaluation of glatiramer’s potential to affect other immune functions, it may interfere with recognition of foreign antigens undermining the body’s tumor surveillance and defense system against infection.

Lipoatrophy

May occur locally at injection site at various times after treatment (sometimes after several months) and may not resolve; to possibly minimize occurrence, advise patients to follow proper injection technique and rotate site with each injection. Skin necrosis has also been observed.

Systemic reactions

Postinjection systemic reactions may occur within minutes of injection and occur in a substantial percentage of patients (~16% [20 mg/mL] and ~2% [40 mg/mL] in studies); symptoms (anxiety, chest pain, constriction of the throat, dyspnea, flushing, palpitations, tachycardia, urticaria) are usually self-limited and transient. These symptoms generally occur several months after initiation of treatment. Concurrent drug therapy concerns:

Drug-drug interactions

Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information. Other warnings/precautions:

Antigenic

Glatiramer acetate is antigenic and may possibly lead to the induction of untoward host responses. Glatiramer acetate-reactive antibodies (IgG subtype) form in most patients.

Pregnancy & Lactation

Pregnancy

FDA category B

Adverse events were not observed in animal reproduction studies. Limited information is available related to the use of glatiramer acetate in pregnancy (Amato 2015; Fragoso 2014; Ghezzi 2013; Giannini 2012). Until additional information is available, consideration should be given to discontinuing treatment if a woman becomes pregnant, or 1 month prior to becoming pregnant in women with mild disease (Coyle, 2012; Ghezzi 2013; Houtchens, 2013; Lu, 2013).

Lactation

Avoid

It is not known if glatiramer acetate is present in breast milk. The manufacturer recommends that caution be exercised when administering glatiramer acetate to breastfeeding women. Although glatiramer acetate would not likely be bioavailable if absorbed orally via breast milk (Amato 2015), it is generally recommended to avoid use if breastfeeding (Amato 2015; Ghezzi 2013; Houtchens 2013).

Biology & Pharmacokinetics

Pharmacokinetics

Drug–drug interactions (1, DDInter)

Interacting drug	Severity	Management
Natalizumab	major

Registered Products (2)

Brand	Form / strength	Pack	Agent	Citizen (JOD)
Galmar 20mg/ml PFS	Pre-filled Syringe 20 mg/ml	30 PFS	MS PHARMA/JORDAN	—
Glitaxon	Pre-filled Syringe 20 mg/ml	2 PFS	Professional Drug Store	—