DiseaseModifying Therapies: Side Effect Management

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Disease-Modifying TherapiesSide Effect
Management

• Patricia Kennedy, RN, CNP, MSCN
• Rocky Mountain MS Center
• Englewood, Colorado
• kennedy_at_mscenter.org

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Adherence vs Compliance

• Compliance connotes unilateral decision making
  and expectations that, if the physician
  prescribes it, the patient should take it
• Adherence connotes a mutually agreed upon plan
  between patient and physician that patients can
  follow and physicians will support

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Nonadherence to Treatment

• Estimated rate of non-adherence is 30 to 50
• Adherence to MS treatments is a complex and
  challenging issue

Rheiner NW. Rehabilitation Nursing Research.
1995490-97.
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Predictors of Adherence to Copaxone Therapy in
Patients with RRMS

• Cira Fraser, PhD, RN, CS, Monmouth University,
  School of Nursing
• Using NARCOMS and Teva data bases, predictors of
  adherence were identified

• Self efficacy
• Hope
• Perception that physician is most supportive of
  person taking glatiramer acetate (Copaxone)
• No previous use of immunomodulating agents

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Predictors of Adherence and Nurses Role

• Self efficacy
• If you believe you can do it, you can!
• Nurses role
• Patient education should be directed to
  strengthen self-efficacy
• Assess coping skills and previous behaviors

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Predictors of Adherence and Nurses Role

• Hope
• The belief that goal achievement will benefit
  individual, that outcomes are controllable, and
  that program is efficacious
• Nurses Role
• Provide patient education directed to the
  benefits of therapy
• Provide long-term data as they become available

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Predictors of Adherence and Nurses Role

• Perception that physician is supportive
• Rates higher than support from spouse, adult
  child, significant other, friend, neighbor, or
  nurse
• Nurses Role
• Discuss with physician
• Do not give 4 kits and say choose
• Do not discuss benign course and then suggest
  therapy
• Do not discontinue therapy based on side effects
  without first working with the patient to manage
  them

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Predictors of Adherence and Nurses Role

• Previous use of DMTs
• May be related to decreased self-efficacy
• Nurses Role
• Do not use term treatment failure
• Educate why other DMTs not helpful
• Patient perception
• Early cessation
• Expectations too high
• Reality

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Why Isnt Everyone with MS on a Therapy?

• Physician beliefs
• Patient beliefs
• Finances
• Side effects
• Concerns
• Actual experiences

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Disease-Modifying Agents

• Glatiramer acetate (Copaxone)
• Interferon beta-1b (Betaseron)
• Interferon beta-1a, IM (Avonex)
• Interferon beta-1a, SC (Rebif)

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Goals for Therapy

• Modify the course of multiple sclerosis
• Fewer lesions on MRI
• Fewer exacerbations and milder exacerbations
• Less disability

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Encouraging Patient Use of Disease-Modifying
Agents

• Education about MS
• Natural history of MS
• Expectations without therapy
• Expectations with therapy
• Realistic expectations
• Outcomes data from trials
• Potential side effects

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Medication Discontinuation

• Side effects
• Injections
• Perceived lack of benefits
• Lack of information
• Economics

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Nurses Role in Successful Therapy Utilization

• Manage side effects
• Provide education
• Disease
• Treatment
• Look at patient predictors to anticipate problems
• Offer ongoing support

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Needle Phobia

• Prevalent in the general population
• 7 - 22
• Self injection presents a greater challenge
• Auto-injectors help some
• Administration by others an option
• True phobias may need psychological intervention
  for patient compliance

Cox, D, Mohr, D, Merluzzi BA. Presented at the
18th Annual Meeting of the Consortium of Multiple
Sclerosis Centers, June 2-6, 2004, Toronto,
Canada. Poster Presentation S08.
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Interferon Side Effects Flu-Like Symptoms

• Flu-like symptoms
• (fever, chills, achiness, headache)
• Typically worse at initiation and for up to 3
  months
• May last for the duration of the use of the
  medication

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Management of Flu-Like Symptoms

• Titrate dose at initiation
• Inject in evening
• Suggest use of NSAIDs
• (non steroidal anti-inflammatory drugs)
• Acetaminophen, ibuprofen, naproxen
• Also have antipyretic benefits
• Take prior to injection and repeat as needed
• Low-dose prednisone

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Interferon Side Effects Injection Site Reactions

• Site reactions
• Skin reactions more common with subcutaneous
  injections
• Range from redness, elevation, and heat to open
  sores
• Pain with injection
• Potential for bleeding, bruising, and abscess
  formation with IM injections

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Management of Injection Site Reactions

• Check technique
• Skin cleansing
• Needle depth
• Rotation of injection sites
• Educate about skin necrosis
• Recommend use of ice, heat, topical anesthetics
• Bring drug to room temperature
• Use auto-injector for consistency

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Interferon Side Effects Skin Necrosis
Sheremata WA, et al. N Engl J Med. 19953321584-1
585.
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Management of Injection Site Reactions

• For IM injections (IFN ß-1a)
• Do not use if patient is taking anticoagulants
• Evaluate body mass may need a shorter needle
• Educate patient to report any injection sites
  that are red, painful, or hot

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Interferon Side Effects Laboratory Abnormalities

• Laboratory abnormalities
• Elevated liver enzymes
• Leukocytopenia
• Thyroid abnormalities

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Management of Laboratory Abnormalities

• Check labs at baseline
• Recheck at 1 month, 3 months, and then every 6
  months
• If abnormal, decrease dose and retitrate
• Check after 1 month and again after patient has
  resumed full dose

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Glatiramer Acetate Side Effects

• Site reactions
• Redness, swelling, itchiness, dryness, pain
• Lipoatrophy
• Blisters or sores

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Management of Injection Site Reactions

• Evaluate injection technique
• Skin cleansing
• Rotation of sites
• Use of auto-injector
• Evaluate body mass
• Apply ice or warmth to site
• Avoid creams or lotions with alcohol in them
• Use of cortisone creams is somewhat controversial

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Glatiramer Acetate Side Effects Lipoatrophy
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Glatiramer Acetate Side Effects Lipoatrophy

• Lipoatrophy
• Can occur early in treatment
• Can occur in multiple sites
• Educate patient not to inject in areas where
  lipoatrophy is occurring
• Icing before and after injection may help prevent

Edgar C, et al. Canadian Journal of Neurological
Sciences, 31200458 63.
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Glatiramer Acetate Side EffectsImmediate
Postinjection Reaction

• Occurs in approximately 10 of patients
• Occurs within short time after injection
• Symptoms include
• Flushing of face
• Chest tightness
• Heart palpitations
• Anxiety
• Shortness of breath
• Pruritus

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Management of Immediate Postinjection Reaction

• 15-minute rule
• Reassure patient
• Not cardiac or pulmonary in origin
• No data to suggest repetitive nature to reaction
  although it can occur again sporadically

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Reassurance Early in Treatment

• Patients are most at risk for discontinuing
  therapy early in treatment
• Schedule a return appointment soon after
  initiating treatment (1 to 3 months)
• Review injection techniques, expectations of
  therapy, side effects, injection sites, and
  potential roadblocks for the patient
• Reiterate the goals for therapy

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Reassurance Over Time

• Evaluate injection sites at every visit
• Question patients about any problems they
  experience related to their therapy
• Review expectations
• Reinforce reason for using therapy
• Long-term data
• MRI
• Neurologic exam

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Reassurance Over Time

• Question the patient about missed injections
• Reinforce the therapeutic alliance, thereby
  encouraging the patient to contact you with any
  problems or hesitations about continuing therapy

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Summary

• Side effects to disease-modifying therapies are
  common
• Most side effects are manageable
• Nurses are in the best position to help patients
  manage them through education, observation, and
  continued support