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PLEGRIDY dosing and administration1

Getting your relapsing multiple sclerosis (MS) patients into the right routine

When factoring dosing and administration into treatment choice for your patients, it’s good to have options. To help meet the needs of your patients, PLEGRIDY offers1:

  • Every-2-weeks dosing
  • Subcutaneous (SC) administration using the PLEGRIDY SC Pen or PLEGRIDY SC prefilled syringe
  • Intramuscular (IM) administration using the PLEGRIDY IM prefilled syringe

Position and press: PLEGRIDY SC Pen1,2

Watch the PLEGRIDY SC Pen injection video

  • Designed for one-handed self-administration
  • Needle remains hidden from start to finish
  • Audible and visual status indicators to ensure drug delivery
  • Injection sites are abdomen, back of upper arm, or thigh
Download PLEGRIGY SC
Pen Instructions for Use

PLEGRIDY SC prefilled syringe1,3

  • SC single-dose prefilled syringe arrives ready to use
  • 29-gauge, 0.5-inch needle is preattached to 1.0 mL capacity glass syringe
  • Injection sites are the abdomen, back of upper arm, or thigh
Download PLEGRIDY SC Prefilled
Syringe Instructions for Use

PLEGRIDY IM prefilled syringe1,4,5

Comparison between SC and IM administration

An open-label, crossover study analyzed findings from 130 healthy volunteers to assess the bioequivalence of single doses of 125 mcg of PLEGRIDY administered as a subcutaneous (SC) and intramuscular (IM) injection.

The primary endpoint of the study was the assessment of bioequivalence based on pharmacokinetics of PLEGRIDY administered subcutaneously and intramuscularly. The pharmacokinetics of 125 mcg single dose of PLEGRIDY administered subcutaneously and intramuscularly were similar.

  • IM prefilled syringe arrives prefilled with 1 dose of PLEGRIDY in solution
  • The tip of the cap of the PLEGRIDY IM prefilled syringe is made of natural rubber latex, which may cause allergic reactions
  • 23-gauge, 1.25-inch needle is included with the syringe but is not pre-attached
  • Injection site is the thigh; patients may alternate between left and right thighs

See the most common adverse reactions with IM versus SC injection from the bioequivalence study

Download PLEGRIDY IM Prefilled
Syringe Instructions for Use

Titration1,6-8

PLEGRIDY should be titrated at the start of treatment to help reduce flu-like symptoms that may occur at the beginning of treatment.

The recommended full dose of PLEGRIDY is 125 mcg by SC or IM injection 1 time every 14 days.

PLEGRIDY is titrated at doses of 63 mcg (dose 1, day 1) and 94 mcg (dose 2, day 15) prior to receiving the full dose (125 mcg).

Switching between the SC and IM routes of administration and vice versa has not been studied. It is not expected that dose titration should be repeated based upon bioequivalence demonstrated between the 2 routes of administration.

PLEGRIDY SC Starter Packs1,6,7

A PLEGRIDY Starter Pack is available for PLEGRIDY SC Pen and PLEGRIDY SC prefilled syringe containing the first 2 doses. Starter Pack devices are color coded to help the patient select the right dose.

PLEGRIDY SC Pen Starter Pack1,6

For Day 1:

One ORANGE pen containing 63 mcg of PLEGRIDY

For Day 15:

One BLUE pen containing 94 mcg of PLEGRIDY

Download PLEGRIDY SC Pen
Starter Pack Instructions for Use

PLEGRIDY SC Prefilled Syringe Starter Pack1,7

For Day 1:

One ORANGE syringe containing 63 mcg of PLEGRIDY

For Day 15:

One BLUE syringe containing 94 mcg of PLEGRIDY

Download PLEGRIDY SC Prefilled Syringe Starter Pack Instructions for Use

PLEGRIDY Titration Kit for use with the PLEGRIDY IM prefilled syringe1,8

The PLEGRIDY Titration Kit comes with 2 titration clips to help ensure the right dose is delivered the first 2 times patients use the IM prefilled syringe. The IM prefilled syringe snaps into the titration clip, which has a collar to ensure the right dose is delivered. The clips are color coded to help the patient select the right clip for each of the first 2 injections. The yellow clip (for dose 1) allows a delivered dose of 63 mcg of PLEGRIDY, and the purple clip (for dose 2) allows a delivered dose of 94 mcg of PLEGRIDY. The PLEGRIDY Titration Kit does not include PLEGRIDY and is intended for use with the PLEGRIDY IM Prefilled Syringe Administration Pack.

PLEGRIDY IM Titration Kit

Titration clip collar

Download PLEGRIDY IM Titration
Kit Instructions for Use

Additional dosing and administration information1

  • PLEGRIDY is for subcutaneous or intramuscular use only
  • Recommended dose for both routes of administration: 125 mcg every 14 days
  • PLEGRIDY dose should be titrated, starting with 63 mcg on day 1, 94 mcg on day 15, and 125 mcg (full dose) on day 29
  • For subcutaneous administration, the usual injection sites are the abdomen, back of the upper arm, and thigh
  • For intramuscular administration, alternate injections between the left and right thighs
  • Rotate injection sites with each administration to minimize the likelihood of severe injection site reactions, including necrosis or localized infection
  • Analgesics and/or antipyretics on treatment days may help ameliorate flu-like symptoms
Learn more about strategies to help
manage common side effects

Storing PLEGRIDY, including while traveling1

Advise patients:

  • Store PLEGRIDY in the original carton to protect it from light

  • Keep PLEGRIDY in the refrigerator between 36° F to 46° F (2° C to 8° C)

  • After removing PLEGRIDY from the refrigerator, allow it to warm to room temperature for about 30 minutes. Do not use external heat sources, such as hot water, to warm PLEGRIDY

  • Do not freeze PLEGRIDY. Discard PLEGRIDY in an FDA-cleared sharps container if it freezes

  • If refrigeration is unavailable, such as during travel, PLEGRIDY may be stored at room temperature up to 25° C (77° F) for a period up to 30 days. PLEGRIDY can be removed from and returned to a refrigerator, if necessary

Watch the PLEGRIDY SC Pen injection video

Watch the PLEGRIDY IM Injection Video

Download the PLEGRIDY Start Form
Prescribe online
See significant results in 3 key measures of disease activity1,2
Next: Support program

Indication

PLEGRIDY® (peginterferon beta-1a) is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

Important Safety Information

CONTRAINDICATIONS

  • PLEGRIDY® (peginterferon beta-1a) is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta or peginterferon, or any other component of the formulation

WARNINGS AND PRECAUTIONS

Hepatic Injury

  • Severe hepatic injury, including hepatitis, autoimmune hepatitis, and rare cases of severe hepatic failure, have been reported with interferon beta. Asymptomatic elevation of hepatic transaminases has also been reported, and in some patients has recurred upon rechallenge with interferon beta. Elevations in hepatic enzymes and hepatic injury have been observed with PLEGRIDY in clinical studies. Monitor liver function tests and patients for signs of hepatic injury. Consider discontinuation of PLEGRIDY if hepatic injury occurs. Cases of noninfectious hepatitis have been reported in the postmarketing setting with use of PLEGRIDY

Depression and Suicide

  • Depression, suicidal ideation, and suicide occur more frequently in patients receiving interferon beta than in patients receiving placebo. Advise patients to report immediately any symptom of depression or suicidal ideation. If a patient develops depression or other severe psychiatric symptoms, consider stopping treatment with PLEGRIDY

Anaphylaxis and Other Allergic Reactions

  • Serious allergic reactions are rare complications of treatment with interferon beta; anaphylaxis has been reported with use of PLEGRIDY in the postmarketing setting. Less than 1% of PLEGRIDY-treated patients experienced a serious allergic reaction such as angioedema or urticaria. Discontinue PLEGRIDY if a serious allergic reaction occurs. The rubber tip cap of the PLEGRIDY prefilled syringe for intramuscular administration contains natural rubber latex, which may cause allergic reactions and should not be handled by latex-sensitive individuals

Injection Site Reactions Including Necrosis

  • Injection site reactions, including injection site necrosis, can occur with the use of interferon beta, including PLEGRIDY. In clinical studies of subcutaneous PLEGRIDY, the incidence of injection site reactions (e.g., injection site erythema, pain, pruritus, or edema) was 66% in the PLEGRIDY group (3% were severe) and 11% in the placebo group (0% were severe). One patient out of 1468 patients who received PLEGRIDY experienced injection site necrosis. In a single clinical study of healthy volunteers comparing single doses of intramuscular and subcutaneous PLEGRIDY, the incidence of injection site reactions (e.g., injection site erythema, pain, pruritus, or edema) was 14% in the intramuscular PLEGRIDY group and 32% in the subcutaneous PLEGRIDY group. Injection site abscesses and cellulitis have been reported in the postmarketing setting with use of interferon beta. Some cases required treatment with hospitalization for surgical drainage and intravenous antibiotics

  • Periodically evaluate patient understanding and use of aseptic self-injection techniques and procedures, particularly if injection site necrosis has occurred. Decisions to discontinue therapy following necrosis at a single injection site should be based on the extent of the necrosis. For patients who continue therapy with PLEGRIDY after injection site necrosis has occurred, avoid administration of PLEGRIDY near the affected area until it is fully healed. If multiple lesions occur, change injection site or discontinue PLEGRIDY until healing occurs

Congestive Heart Failure

  • Congestive heart failure, cardiomyopathy, and cardiomyopathy with congestive heart failure occur in patients receiving interferon beta. The incidence of cardiovascular events was 7% in both PLEGRIDY and placebo treatment groups. Monitor patients with significant cardiac disease for worsening of their cardiac condition during initiation and continuation of treatment with PLEGRIDY

Decreased Peripheral Blood Counts

  • Interferon beta can cause decreased peripheral blood counts in all cell lines, including rare instances of pancytopenia and severe thrombocytopenia. Decreases in white blood cell counts below 3.0 x 109/L occurred in 7% of patients receiving PLEGRIDY and in 1% receiving placebo. The incidence of clinically significant decreases in lymphocyte counts (below 0.5 x 109/L), neutrophil counts (below 1.0 x 109/L), and platelet counts (below 100 x 109/L) were all less than 1% and similar in both placebo and PLEGRIDY groups. Monitor patients for infections, bleeding, and symptoms of anemia. Monitor complete blood cell counts, differential white blood cell counts, and platelet counts during treatment with PLEGRIDY. Patients with myelosuppression may require more intensive monitoring of blood cell counts

Thrombotic microangiopathy

  • Cases of thrombotic microangiopathy (TMA), including thrombotic thrombocytopenic purpura and hemolytic uremic syndrome, some fatal, have been reported several weeks to years after starting interferon beta products. Discontinue PLEGRIDY if clinical symptoms and laboratory findings consistent with TMA occur, and manage as clinically indicated

Pulmonary Arterial Hypertension

  • Cases of pulmonary arterial hypertension (PAH) have been reported in patients treated with interferon beta products, including PLEGRIDY. PAH has occurred in patients treated with interferon beta products in the absence of other contributory factors. Many of the reported cases required hospitalization, including one case with interferon beta in which the patient underwent a lung transplant. PAH has developed at various time points after initiating therapy with interferon beta products and may occur several years after starting treatment. Patients who develop unexplained symptoms (e.g., dyspnea, new or increasing fatigue) should be assessed for PAH. If alternative etiologies have been ruled out and a diagnosis of PAH is confirmed, discontinue treatment and manage as clinically indicated

Autoimmune disorders

  • Autoimmune disorders of multiple target organs including idiopathic thrombocytopenia, hyper- and hypothyroidism, and autoimmune hepatitis have been reported with interferon beta. The incidence of autoimmune disorders was less than 1% in both PLEGRIDY and placebo treatment groups. If patients develop a new autoimmune disorder, consider stopping PLEGRIDY

Seizures

  • Seizures are associated with the use of interferon beta. The incidence of seizures in clinical studies was less than 1% in patients receiving PLEGRIDY and placebo. Exercise caution when administering PLEGRIDY to patients with a seizure disorder

MOST COMMON SIDE EFFECTS

  • The most common adverse reactions in clinical trials of subcutaneous PLEGRIDY (incidence ≥10% and at least 2% more frequent on PLEGRIDY than on placebo) were injection site erythema, influenza-like illness, pyrexia, headache, myalgia, chills, injection site pain, asthenia, injection site pruritus, and arthralgia

Please see full Prescribing Information.

References: 1. PLEGRIDY Prescribing Information. Cambridge, MA: Biogen. 2. PLEGRIDY SC Single-Dose Prefilled Pen Instructions for Use. Cambridge, MA: Biogen. 3. PLEGRIDY SC Single-Dose Prefilled Syringe Instructions for Use. Cambridge, MA: Biogen. 4. Zhao Y, Chen K, Ramia N, et al. Bioequivalence of intramuscular and subcutaneous peginterferon beta-1a: results of a phase I, open-label crossover study in healthy volunteers. Ther Adv Neurol Disord. 2021;14:1-11. 5. PLEGRIDY IM Single-Use Prefilled Syringe Instructions for Use. Cambridge, MA: Biogen. 6. PLEGRIDY SC Single-Dose Prefilled Pen Starter Pack Instructions for Use. Cambridge, MA: Biogen. 7. PLEGRIDY SC Single-Dose Prefilled Syringe Starter Pack Instructions for Use. Cambridge, MA: Biogen.
8. PLEGRIDY Titration Kit Instructions for Use. Cambridge, MA: Biogen. 9. Calabresi PA, Kieseier BC, Arnold DL, et al. Pegylated interferon beta-1a for relapsing-remitting multiple sclerosis (ADVANCE): a randomised, phase 3, double-blind study. Lancet Neurol. 2014;13(7):657-665.

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